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 2013-04-02 for BREMER 3D CROWN FULL ASSEMBLY 292301001 manufactured by Depuy Synthes Spine.
[3255637]
International affiliate reports that during application of the 3d halo crown assembly, one skull pin penetrated the patient's skull. The pin was removed and replaced and the halo crown was applied. The patient is reported to have not have any health problems and no additional treatment was required. It was reported that the patient's bone quality is not very good.
Patient Sequence No: 1, Text Type: D, B5
[10609320]
No lot number or sample was available. Without a lot number, a review of manufacturing records cannot be completed. Without a product sample, we are unable to confirm the reported issue or identify the root cause. Review of complaint data found no emerging trends. No other complaints of this nature have been reported for the past twelve months. The patient is reported to have poor bone quality which may have contributed to the event. At this time, the complaint is considered to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2013-14720 |
| MDR Report Key | 3030249 |
| Report Source | 01,05,07 |
| Date Received | 2013-04-02 |
| Date of Report | 2013-03-05 |
| Date of Event | 2013-03-01 |
| Date Mfgr Received | 2013-03-05 |
| Date Added to Maude | 2013-04-02 |
| 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 | 3 |
| Manufacturer Contact | BETH BECOTTE |
| Manufacturer Street | 326 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283575 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER 3D CROWN FULL ASSEMBLY |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2013-04-02 |
| Catalog Number | 292301001 |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-02 |