MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2004-07-22 for MAYFIELD 4-0-A-2020 A2020 manufactured by Integra Lifesciences Corporation.
[27941852]
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.
Patient Sequence No: 1, Text Type: N, H10
[27941853]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2004-00007 |
| MDR Report Key | 5137025 |
| Report Source | OTHER |
| Date Received | 2004-07-22 |
| Date Mfgr Received | 2004-06-21 |
| Device Manufacturer Date | 2004-06-04 |
| Date Added to Maude | 2015-10-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GENE WEBBER |
| Manufacturer Street | 4900 CHARLEMAR DR., |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal | 45227 |
| Manufacturer Phone | 5132729113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2004-00007R |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAYFIELD |
| Generic Name | SKULL PINS |
| Product Code | HAX |
| Date Received | 2004-07-22 |
| Model Number | 4-0-A-2020 |
| Catalog Number | A2020 |
| Lot Number | 42358 |
| Device Availability | * |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 4900 CHARLEMAR DR., CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-07-22 |