FDA Adverse Event
Injury
Summary report: N
MMF SCREW
MDR report key: 3022746
·
Received March 22, 2013
Report
- Report Number
- 9610905-2013-00009
- Event Type
- Injury
- Date Received
- March 22, 2013
- Date of Event
- March 21, 2013
- Report Date
- March 21, 2013
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
- Product Code
- DZL
- PMA / PMN Number
- K042573
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE OF TWO RELATED MDR'S. REFER TO 9610905-2013-00010.
Description of Event or Problem · 1
SURGEON WAS USING MMF SCREWS TO CONSOLIDATE FRACTURE. MMF SCREWS BROKE NEAR THE HEAD UPON REMOVAL. BOTTOM PORTION OF SCREWS WILL REMAIN IMPLANTED. PATIENT HEALTH WAS NOT COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119192 | MMF SCREW | DZL | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | 25-092-08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |