MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-02 for BREMMER HALO * HT026 manufactured by Depuy Acromed.
[319603]
During halo placement two of the four pins became lodged and very difficult to remove from the rings. After removal, upon inspection it was visible that the pin threads and rings had cold welded. Two new pins placed without incident.
Patient Sequence No: 1, Text Type: D, B5
[339989]
Add'l info rec'd from mfr 9/9/04: mfr is currently in the process of gathering the info required and will respond as soon as the info is available.
Patient Sequence No: 1, Text Type: D, B5
[343390]
Add'l info rec'd form mfr 9/30/04: previous submitted report: not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 532990 |
| MDR Report Key | 532990 |
| Date Received | 2004-07-02 |
| Date of Report | 2004-06-22 |
| Date of Event | 2004-06-12 |
| Date Facility Aware | 2004-06-21 |
| Report Date | 2004-06-22 |
| Date Added to Maude | 2004-07-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMMER HALO |
| Generic Name | HALO |
| Product Code | KQZ |
| Date Received | 2004-07-02 |
| Model Number | * |
| Catalog Number | HT026 |
| Lot Number | 46986 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 522262 |
| Manufacturer | DEPUY ACROMED |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-02 |