FDA Adverse Event
Injury
Summary report: N
PURIST
MDR report key: 18673451
·
Received February 8, 2024
Report
- Report Number
- 3006119126-2024-00001
- Event Type
- Injury
- Date Received
- February 8, 2024
- Date of Event
- December 4, 2023
- Report Date
- February 8, 2024
- Manufacturer
- JOSSI AG
- Product Code
- BWN
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
MANUFACTURE INVESTIGATED THE TRAINING OF THE USERS, STATE OF FUNCTIONING OF THE DEVICE, STATE OF HEALTH OF PATIENT INCLUDING BONE QUALITY, AND CONFIRMED SURGEON FOLLOWED IFU AND SURGICAL PRCEDURE. NO FAILURES OR DEVIATIONS HVE BEEN FOUND. THE PATIENT'S BONE QUALITY IS UNKNOWN AND IS THE MOST LIKELY CAUSE OF THE FRACTURE.
Description of Event or Problem · 0
ON THE DAY AFTER HIP SURGERY DONE WITH USING PURIST LEG POSITIONING SYSTEM, PATIENT COMPLAINED OF SWELLING IN THE ANKLE AND A BIT OF DISCOMFORT. PATIENT LET THE SURGEON KNOW ABOUT 10 DAYS AFTER SURGERY. SURGEON ORDERED X-RAY WHICH SHOWED A DISPLACED FRACTURE OF THE ANKLE (SPECIFIC BONE NOT PROVIDED). PATIENT PUT IN A STIRRUP BRACE BUT NO SURGERY REQUIRED. PATIENT HAS NOT BEEN TO A FOLLOW UP APPOINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1389207 | PURIST | TABLE AND ATTACHMENTS - OPERATING ROOM- LEG POSITIONING SYSTEM | BWN | JOSSI AG | 6813100.00093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other| R |