FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
MDR report key: 15475602
·
Received September 24, 2022
Report
- Report Number
- 3012447612-2022-00214
- Event Type
- Malfunction
- Date Received
- September 24, 2022
- Report Date
- September 29, 2022
- Manufacturer
- ZIMMER BIOMET SPINE INC.
- Product Code
- NKB
- PMA / PMN Number
- SEE-H10
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
PMA/510K: THE 510K IS UNKNOWN, BUT IS LIKELY EITHER K132884 OR K111301. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Additional Manufacturer Narrative · 0
THIS EVENT IS BEING RECORDED IN 3003853072-2022-00008.
Description of Event or Problem · 0
A PATIENT REPORTED THAT THEY HAD A SPINE IMPLANT THAT BROKE POST-OP. NO FURTHER INFORMATION WAS PROVIDED.
Description of Event or Problem · 0
THIS REPORT IS BEING REPLACED BY 3003853072-2022-00008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1874559 | UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT | UNKNOWN LUMBAR IMPLANT | NKB | ZIMMER BIOMET SPINE INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |