MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2008-12-23 for BREMER 3D HALO CROWN SYSTEM 292301000 manufactured by Depuy Spine, Inc..
[981489]
Initial application of a skull brace was done for dens fracture in 2008. The user noted that when he tightened the pins to set the product on the patient, one of the left posterior pins was loose and easily moved forward. The contact in other country reported that the skull pin had been re-tightened after the initial fitting. The following month, it was found the skull pin had penetrated through the bone. Contact reported no significant patient complication at this time.
Patient Sequence No: 1, Text Type: D, B5
[8168571]
Note: this event occurred with a sterile version of the 3d crown that is sold only in other country (catalog number 292301001). As the equivalent device, non-sterile, is sold in the usa as we have filed this mdr using the fda cleared catalog number. No connection could be made between the reported event and any shortcoming of the device. Care must be taken during application and subsequent tightening to ensure that skull pins do not advance through the bone.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2008-00212 |
| MDR Report Key | 1275052 |
| Report Source | 01,05,07 |
| Date Received | 2008-12-23 |
| Date Mfgr Received | 2008-11-28 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-01-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER 3D HALO CROWN SYSTEM |
| Generic Name | HAX/TONG, SKULL FOR TRACTION |
| Product Code | HAX |
| Date Received | 2008-12-23 |
| Model Number | NA |
| Catalog Number | 292301000 |
| Lot Number | 060395 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-23 |