FDA Adverse Event
Other
Summary report: N
2.0X0.6 2/2 HOLE LEFT MED L PLATE
MDR report key: 1068859
·
Received June 30, 2008
Report
- Report Number
- 1032347-2008-00034
- Event Type
- Other
- Date Received
- June 30, 2008
- Date of Event
- May 20, 2008
- Report Date
- June 3, 2008
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- PMA / PMN Number
- K654886
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
PLATES & SCREWS IMPLANTED IN MAXILLA IN 2007. PATIENT CAME IN FOR CHECK UP AT 3 MONTHS, DOCTOR NOTICED SOME MOVEMENT. AT 6 MONTH CHECK UP, TOOK X-RAYS, DETERMINED PLATE WAS BROKEN. REMOVED IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.0X0.6 2/2 HOLE LEFT MED L PLATE | BONE PLATE | JEY | BIOMET MICROFIXATION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | SCREWS WERE USED| UNKNOWN HOW MANY AND WHICH PART NUMBER. |