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 2016-06-27 for 3-D HALO CROWN SYSTEM (TYVEK) 292301001 manufactured by Depuy Synthes Spine.
[48307390]
(b)(4). If additional information becomes available, the mdr decision will be revisited at that time. 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
[48307391]
A surgery was performed on (b)(6) 2016 to install a halo vest system for fracture. After the patient was fitted with the halo vest, the surgeon tried to extract a one of the screw of the reported 3d halo crown set for re-adjustment. However, the screw could not be extracted. The installation of the halo vest was eventually aborted. There was no surgical delay. The surgery was rescheduled and will be performed on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[50969628]
One (1) 3d halo crown system was returned for evaluation. Visual examination revealed that one of the skull pins was struck inside the crown. The returned set consists of four other skulls pins. The crown and the skull pins showed signs of operative use. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. No emerging trends were found requiring further actions. A definitive root cause cannot be determined for the skull pins being struck in the reported halo crown set. However, a potential root cause may be inadvertently cross threading the skull pin during insertion. Attempting to tighten the skull pin in this state may have placed unexpectedly high amounts of force on the thread, resulting in it becoming lodged in the crown. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required. 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
| Report Number | 1526439-2016-10453 |
| MDR Report Key | 5751513 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-27 |
| Date of Report | 2016-05-31 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-07-15 |
| Date Added to Maude | 2016-06-27 |
| 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 | MEDOS INTERNATIONAL SARL |
| 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 | 3-D HALO CROWN SYSTEM (TYVEK) |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2016-06-27 |
| Returned To Mfg | 2016-06-21 |
| Catalog Number | 292301001 |
| Lot Number | 062075 |
| 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. Other; 2. Required No Informationntervention | 2016-06-27 |