MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-12-05 for BREMER HALO SYSTEM PT002 manufactured by Depuy Acromed, Inc..
[236877]
It was reported to depuy acromed that the securing threaded knobs on the lateral portion of the halo were broken, causing the halo to loosen. According to the complaintant, this break occurred eleven days after initial application. The patient's spine was stabiled and another halo was applied. A complaint history was performed and no other complaints have been reported for this part number. A dimensional analysis was performed and the halo conformed to specifications. And exact cause of the event cannot be determined, it is possible that the halo securing screw could have been over-torqued during application, causing the knob to fracture. The material of the threaded securing knobs is being changed from plastic to aluminum. This will increase the strength and durability of the knobs, and should prevent this type of event from recurring. No further action is required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2001-00060 |
| MDR Report Key | 364193 |
| Report Source | 08 |
| Date Received | 2001-12-05 |
| Date of Report | 2001-12-05 |
| Date Mfgr Received | 2001-11-05 |
| Date Added to Maude | 2001-12-07 |
| 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 | PEDIATRIC HALO |
| Product Code | KQZ |
| Date Received | 2001-12-05 |
| Model Number | NA |
| Catalog Number | PT002 |
| Lot Number | 043136 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 353294 |
| Manufacturer | DEPUY ACROMED, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | BREMER HALO SYSTEM |
| Baseline Generic Name | PEDIATRIC HALO |
| Baseline Model No | NA |
| Baseline Catalog No | PT002 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-12-05 |