MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-08-31 for BREMER HALO SYSTEM AC020 manufactured by Depuy Acromed, Inc..
[218750]
It was reported to depuy acromed that a pt in a cervical halo had skull pins penetrate the skull bone. The pt was in an accident in 1999. Pt was placed in a halo and the halo was removed three months later. A year later, the pt complained of neck pain and it was discovered that proper fusion did not occur. The pt was surgically instrumented as well as placed in another halo. Six weeks later, the pt complained of severe pain at the pin sites. Two pins had penetrated the skull. The pins were removed and new ones were placed at adjacent sites. One week later, a third pin had penetrated the skull. At this time the halo was removed and the patient was placed in a cervical thoracic orthosis. According to the surgeon, the pt has a history of drug and alcohol abuse and the dr suggested that the pt could have been manipulating their own pins to gain access to pain medications. A complaint history analysis was performed and no other complaints have been reported for this part number. The parts were not returned as they were discarded by the hospital. A definitive cause of the event cannot be determined as the parts were not returned for eval. There have been no other compalaints reported for this part number, the event is most likely not device related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2001-00042 |
| MDR Report Key | 349809 |
| Report Source | 07 |
| Date Received | 2001-08-31 |
| Date of Report | 2001-08-31 |
| Date Mfgr Received | 2001-08-21 |
| Date Added to Maude | 2001-09-05 |
| 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 | BREMER HALO SYSTEM |
| Generic Name | HIFIX SKULL PIN |
| Product Code | HAX |
| Date Received | 2001-08-31 |
| Model Number | NA |
| Catalog Number | AC020 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 339118 |
| Manufacturer | DEPUY ACROMED, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | BREMER HALO SYSTEM |
| Baseline Generic Name | HIFIX SKULL PIN |
| Baseline Model No | NA |
| Baseline Catalog No | AC020 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-31 |