MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-04-04 for BREMER 3D CROWN 292301000 manufactured by Depuy Acromed, Inc..
[280494]
It was reported to depuy acromed that a screw jammed in the screw hole of a bremer halo. According to the complainant, the screw jammed and the halo had to be removed and replaced with another halo. There were no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2002-00017 |
| MDR Report Key | 388525 |
| Report Source | 07 |
| Date Received | 2002-04-04 |
| Date of Report | 2002-04-04 |
| Date Mfgr Received | 2002-03-19 |
| Date Added to Maude | 2002-04-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER 3D CROWN |
| Generic Name | CROWN |
| Product Code | HAX |
| Date Received | 2002-04-04 |
| Model Number | NA |
| Catalog Number | 292301000 |
| Lot Number | 044119 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 377565 |
| Manufacturer | DEPUY ACROMED, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | BREMER 3D CROWN |
| Baseline Generic Name | SKULL TONGS |
| Baseline Model No | NA |
| Baseline Catalog No | 292301000 |
| Baseline ID | NA |
| Baseline Device Family | BREMER HALO SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-04 |