MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-11-12 for BREMER ADJUSTIBLE RING HT002 manufactured by Bremer Medical, Inc.
[20760913]
The ring from the halo was put on the pt in order to put the pt in traction prior to putting on the halo vest. The orthotist had difficulty when he attempted to put on the traction bales because the bolts would not gain a purchase on the ring. He used a couple of longer bolts that he had in his possession. The traction bale and ring functioned well for five days, after which time the traction bale was removed and the pt put in an airflo vest. One half day later the pt noted that he could move his head. When the orthotist tried to tighten the bolts, they stripped the threads in the ring. When he tried to tighten the other four bolts that hold the ring together, they also stripepd. The halo vest was removed and the pt was put into another system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035798-1998-00001 |
| MDR Report Key | 196948 |
| Report Source | 05,06 |
| Date Received | 1998-11-12 |
| Date of Report | 1998-08-27 |
| Date of Event | 1998-08-26 |
| Date Mfgr Received | 1998-10-12 |
| Date Added to Maude | 1998-11-17 |
| 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 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER ADJUSTIBLE RING |
| Generic Name | ORTHOTIC BRACE |
| Product Code | HAX |
| Date Received | 1998-11-12 |
| Returned To Mfg | 1998-08-31 |
| Model Number | NA |
| Catalog Number | HT002 |
| Lot Number | 28761 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 191351 |
| Manufacturer | BREMER MEDICAL, INC |
| Manufacturer Address | 4801 DAWIN RD JACKSONVILLE FL 322079512 US |
| Baseline Brand Name | BREMER ADJUSTABLE RING |
| Baseline Generic Name | SKULL TONGS |
| Baseline Model No | NA |
| Baseline Catalog No | HT002 |
| Baseline ID | NA |
| Baseline Device Family | BREMER HALO SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K915800 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-11-12 |