MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-03-12 for ACE HALO SYSTEM 601D manufactured by Depuy Acromed, Inc..
[19164232]
It was reported to depuy acromed that a halo ring broke during post application of the ring. The ring broke on one side of the head and pulled out of position. Another ring and 6 pins had to be applied once the broken ring was removed. There were no other adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2002-00012 |
| MDR Report Key | 382309 |
| Report Source | 07 |
| Date Received | 2002-03-12 |
| Date of Report | 2002-03-12 |
| Date of Event | 2002-02-01 |
| Date Mfgr Received | 2002-02-21 |
| Date Added to Maude | 2002-03-20 |
| 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 DRIVE |
| 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 | ACE HALO SYSTEM |
| Generic Name | HALO |
| Product Code | KQZ |
| Date Received | 2002-03-12 |
| Model Number | NA |
| Catalog Number | 601D |
| Lot Number | 042048 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 371358 |
| Manufacturer | DEPUY ACROMED, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | ACE HALO SYSTEM |
| Baseline Generic Name | HALO |
| Baseline Model No | NA |
| Baseline Catalog No | 601D |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-12 |