FDA Adverse Event
Malfunction
Summary report: N
9-10MM EZLOC FEMORAL FIXATION STD.
MDR report key: 1193148
·
Received October 8, 2008
Report
- Report Number
- 2027970-2008-00029
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Date of Event
- August 8, 2008
- Report Date
- September 18, 2008
- Manufacturer
- BIOMET SPORTS MEDICINE
- Product Code
- MBI
- PMA / PMN Number
- K041261
- Removal / Correction Number
- 2027970-9/18/08-004-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
USER FACILITY; HOSPITAL.
Description of Event or Problem · 1
CUSTOMER OPENED A 9-10MM STD EZLOC AND FOUND THAT THE STERILE PACKAGE CONTAINED A 9-10MM LONG EZLOC. THE MISLABELED PRODUCT WAS NOT USED. THE CASE WAS COMPLETED USING A DIFFERENT LOT OF 9-10MM STD. THIS OCCURRENCE DID NOT CAUSE A DELAY IN THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9-10MM EZLOC FEMORAL FIXATION STD. | MBI | BIOMET SPORTS MEDICINE | 904781 | L164080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |