MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-07 for BREMER 3D HALO CROWN 292301001 manufactured by Depuy Synthes Spine.
[91213716]
Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the findings. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[91213717]
On (b)(6), surgery for cervical hangman's fracture was performed using the halo system. Ten days after the surgery, the surgeon confirmed that the screws, which were fixed on the crown and vest, were broken and its fixation force was lost. On (b)(6), the surgeon performed the revision surgery where the halo in use was removed and a new device was fixed. The revision surgery was successfully completed with a 30-minute delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2017-10939 |
| MDR Report Key | 7005866 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-11-14 |
| Date Added to Maude | 2017-11-07 |
| 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 | 3 |
| Manufacturer Contact | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808201 |
| 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 HALO CROWN |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2017-11-07 |
| Returned To Mfg | 2017-10-20 |
| Model Number | 292301001 |
| Catalog Number | 292301001 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-11-07 |