FDA Adverse Event
Injury
Summary report: N
PATIENT SPECIFIC IMPLANT
MDR report key: 2426404
·
Received January 17, 2012
Report
- Report Number
- 2520274-2012-00080
- Event Type
- Injury
- Date Received
- January 17, 2012
- Date of Event
- January 17, 2012
- Report Date
- December 25, 2011
- Product Code
- KKY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Description of Event or Problem · 1
PATIENT STATUS POST PATIENT SPECIFIC IMPLANT, IMPLANTED ON AN UNKNOWN DATE WAS DISCOVERED TO HAVE AN INFECTION ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OPERATING ROOM (B)(6) 2011 AND IMPLANT WAS REMOVED. SURGEON WILL MONITOR PATIENT UNTIL THE INFECTION CLEARS, WILL RE-EVALUATE THE PATIENT FOR FURTHER TREATMENT. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATIENT SPECIFIC IMPLANT | KKY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SCREW| PLATE| PSI |