FDA Adverse Event
Injury
Summary report: N
PRODISC-L IMPLANT SUPERIOR ENDPLATE
MDR report key: 2042158
·
Received March 28, 2011
Report
- Report Number
- 2530088-2011-00089
- Event Type
- Injury
- Date Received
- March 28, 2011
- Report Date
- March 1, 2011
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MJO
- PMA / PMN Number
- P050010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
PATIENT IMPLANTED WITH PRODISC-L AT L5-S1 ON (B)(6) 2011. THE IMPLANT WAS INTACT AND FUNCTIONING, ALTHOUGH THE PATIENT WAS HAVING LEG PAIN. REPORTEDLY, THE IMPLANT WAS PLACED TOO FAR POSTERIOR. THE IMPLANT WAS REMOVED AND AN ANTERIOR FUSION WAS PERFORMED ON (B)(6) 2011. THIS IS THE 1ST OF 3 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRODISC-L IMPLANT SUPERIOR ENDPLATE | PRODISC-L IMPLANT | MJO | SYNTHES BRANDYWINE | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | POLYETHYLENE INLAY| INFERIOR ENDPLATE |