ReWalk (now Lifeward) Personal 6.0: lateral tibial plateau fracture in a new user (FDA MAUDE)
[INJURY]Dec 18, 2019 · Lifeward · ReWalk Personal 6.0 · Marlborough
Failure Mode
INJURY
Event Date
Dec 18, 2019
Primary Entity
Lifeward
Robotic Platform
ReWalk Personal 6.0
Jurisdiction / Location
Marlborough
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
An FDA MAUDE injury report describes a new user of the ReWalk Personal 6.0 powered exoskeleton sustaining a lateral tibial plateau fracture. ReWalk Robotics rebranded to Lifeward in 2024. Distinct from the 2017 ReWalk tibia/fibula recall (a recall, not a MAUDE report). Source: FDA MAUDE MDR key 10050473, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- Inspect Filing
https://www.lifeward.com/
https://www.lifeward.com/
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7443771&pc=PHL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7443771&pc=PHL
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Details
Incident Context & FAQ
What happened in ReWalk (now Lifeward) Personal 6.0: lateral tibial plateau fracture in a new user (FDA MAUDE)?
An FDA MAUDE injury report describes a new user of the ReWalk Personal 6.0 powered exoskeleton sustaining a lateral tibial plateau fracture. ReWalk Robotics rebranded to Lifeward in 2024. Distinct from the 2017 ReWalk tibia/fibula recall (a recall, not a MAUDE report). Source: FDA MAUDE MDR key 10050473, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on December 18, 2019 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in ReWalk (now Lifeward) Personal 6.0: lateral tibial plateau fracture in a new user (FDA MAUDE)?
ReWalk Personal 6.0 by Lifeward is the recorded robot involved in this incident at Marlborough.
Has anyone responded to ReWalk (now Lifeward) Personal 6.0: lateral tibial plateau fracture in a new user (FDA MAUDE)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of ReWalk (now Lifeward) Personal 6.0: lateral tibial plateau fracture in a new user (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.