MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2005-10-05 for BREMER 3D HALO 292301000 manufactured by Depuy Spine, Inc..
[15219384]
Two skulls pins were inserted through the anterior sliders of the crown. When they tried to retract the pins slightly, they got caught in the threads and could not be removed. Surgeon used another crown to complete the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2005-00215 |
| MDR Report Key | 693301 |
| Report Source | 01,07,08 |
| Date Received | 2005-10-05 |
| Date of Event | 2005-08-02 |
| Date Mfgr Received | 2005-09-07 |
| Date Added to Maude | 2006-03-31 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| 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 3D HALO |
| Generic Name | TRACTION CROWN |
| Product Code | HAX |
| Date Received | 2005-10-05 |
| Returned To Mfg | 2005-09-28 |
| Model Number | NA |
| Catalog Number | 292301000 |
| Lot Number | 050482 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 682429 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | BREMER 3D CROWN |
| Baseline Generic Name | SKULL TONGS |
| Baseline Model No | NA |
| Baseline Catalog No | 292301000 |
| Baseline ID | NA |
| Baseline Device Family | BREMER HALO SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-05 |