FDA Adverse Event
Malfunction
Summary report: N
PROPLAN CMF
MDR report key: 18252470
·
Received December 1, 2023
Report
- Report Number
- 3003998208-2023-00023
- Event Type
- Malfunction
- Date Received
- December 1, 2023
- Date of Event
- November 2, 2023
- Report Date
- November 2, 2023
- Manufacturer
- MATERIALISE NV
- Product Code
- JEY
- UDI-DI
- 05420060350016
- PMA / PMN Number
- K103136
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SECTION D4 - SERIAL NUMBER HAS BEEN DELETED AS IT IS NOT PRESENT IN THE LABEL. BASIC UDI-DI WAS DELETED AND PRIMARY UDI-DI WAS FILLED IN INSTEAD. - UDI RELATED DATA QUALITY UPDATES ONLY SECTION G6- TYPE OF REPORT CHANGED FROM "INITIAL" TO "FOLLOW-UP #:1"
Additional Manufacturer Narrative · 0
KNEE AND FOOT MARKER WERE POSITIONED INCORRECTLY ON THE FIBULA GUIDE.
Description of Event or Problem · 0
IT WAS REPORTED THAT ON FIBULA GUIDE LABELS FOR KNEE/ANKLE WERE SWAPPED. THIS WAS NOTICED IMMEDIATELY DURING SURGERY, THERE WAS NO PATIENT HARM INVOLVED.
Description of Event or Problem · 0
IT WAS REPORTED THAT ON FIBULA GUIDE LABELS FOR KNEE/ANKLE WERE SWAPPED. THIS WAS NOTICED IMMEDIATELY DURING SURGERY, THERE WAS NO PATIENT HARM INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1632510 | PROPLAN CMF | PATIENT SPECIFIC GUIDE, BONE GRAFT HARVESTING | JEY | MATERIALISE NV | SD900.102 | MU23DEXDUT | 05420060350016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Other |