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 2017-08-28 for VIPER2 CANNUALATED AWL 286715210 manufactured by Depuy-synthes Spine.
[83787013]
(b)(4). Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer. The product was released accomplishing all quality requirements. Awaiting sample: a follow up report will be filed upon completion of the investigation. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device not yet returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[83787014]
During inspection on (b)(6) 2017 orthokit specialist found out 2 devices with damage: code 286725420, lot gm3982501 the introduction jammed inserter guide wire screw (holder). Code 286715210, lot ng41908 broke off one of the three teeth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2017-10706 |
| MDR Report Key | 6824488 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-28 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2017-09-18 |
| Device Manufacturer Date | 2013-10-31 |
| Date Added to Maude | 2017-08-28 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 | VIPER2 CANNUALATED AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2017-08-28 |
| Returned To Mfg | 2017-09-01 |
| Model Number | 286715210 |
| Catalog Number | 286715210 |
| Lot Number | NG41908 |
| 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 | 2017-08-28 |