MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-03-14 for BREMER HALO SYSTEM UNK manufactured by Depuy Acromed, Inc..
[17832357]
A halo had to be removed from a patient after twelve days. According to the complainant, the patient was placed in the halo due to a fractured 2nd vertebrae. During the twelve days, the front screws came loose from the skull three separate times. These front screws were then removed, leaving only the side screws. A few days later, the halo was removed. The complainant believes that the event was caused by improper application of the device. The part and lot numbers were unknown and the product will not be returned. There were no other adverse consequences to the patient. Since the product and lot information was not known and the product will not be returned, no further evaluation can be performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2003-00018 |
| MDR Report Key | 448491 |
| Report Source | 04 |
| Date Received | 2003-03-14 |
| Date of Report | 2003-03-14 |
| Date Mfgr Received | 2003-03-12 |
| Date Added to Maude | 2003-03-20 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER HALO SYSTEM |
| Generic Name | HALO |
| Product Code | KQZ |
| Date Received | 2003-03-14 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 437474 |
| Manufacturer | DEPUY ACROMED, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-14 |