FDA Adverse Event
Other
Summary report: N
MIMIX 10 GRAMS
MDR report key: 1313204
·
Received February 12, 2009
Report
- Report Number
- 1032347-2009-00020
- Event Type
- Other
- Date Received
- February 12, 2009
- Date of Event
- January 23, 2009
- Report Date
- January 28, 2009
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- LYC
- PMA / PMN Number
- K003494
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A F/U REPORT WILL BE SENT. TWO LOTS OF PRODUCT WERE USED IN ONE CASE, SEE 1032347-2009-00019 FOR THE ADD'L LOT.
Description of Event or Problem · 1
A 30CC OF MIMIX WAS IMPLANTED ON (B)(6)2009 WITH A HARD TISSUE REPLACEMENT (HTR) IMPLANT AND TISSEAL WAS USED AS A SEALANT. ON (B)(6)2009, PT DEVELOPED A CSF LEAK, A REVISION SURGERY WAS DONE. DURING THE REVISION SURGERY, THE MIMIX WAS FOUND TO BE CRACKED IN FIVE PLACES, AND WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIMIX 10 GRAMS | BONE VOID FILLER | LYC | BIOMET MICROFIXATION | 271130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization |