FDA Adverse Event
Malfunction
Summary report: N
MAYFIELD
MDR report key: 5137025
·
Received July 22, 2004
Report
- Report Number
- 3004608878-2004-00007
- Event Type
- Malfunction
- Date Received
- July 22, 2004
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- HAX
- Removal / Correction Number
- 2004-00007R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INTEGRA LIFESCIENCES CORPORATION DETECTED A FRACTURING CONDITION DURING THE INSPECTION PROCESS OF THE SKULL PIN. RADIOLUCENT SKULL PINS SUSPECTED OF HAVING THIS CONDITION WAS TRACED TO LOT# 42358.
Description of Event or Problem · 1
LOT #42358 IS SUSPECTED OF HAVING SKULL PINS THAT POSSIBLY COULD FRACTURE WHEN UNDER COMPRESSION. THERE HAVE BEEN NO FIELD REPORTED INJURIES OR INCIDENTS INVOLVING THE RADIOLUCENT SKULL PINS. INTEGRA LIFESCIENCES IS VOLUNTARILY RECALLING ALL 40A2020 SKULL PINS WITH LOT #42358.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD | SKULL PINS | HAX | INTEGRA LIFESCIENCES CORPORATION | 4-0-A-2020 | 42358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |