MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2009-11-30 for DRILL GUIDE FOR DIAM 3.5 SCREW 219635ND manufactured by Newdeal.
[1388967]
The reporter stated that during tibial osteotomy surgery, the device broke whilst it was being unscrewed from the plate. Integra has requested add'l clinical info.
Patient Sequence No: 1, Text Type: D, B5
[8338995]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2009-00054 |
| MDR Report Key | 1556017 |
| Report Source | 07,08 |
| Date Received | 2009-11-30 |
| Date of Report | 2009-11-25 |
| Date of Event | 2009-11-02 |
| Date Mfgr Received | 2009-11-02 |
| Date Added to Maude | 2010-07-06 |
| 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 | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL GUIDE FOR DIAM 3.5 SCREW |
| Generic Name | ADVANSYS |
| Product Code | LXI |
| Date Received | 2009-11-30 |
| Catalog Number | 219635ND |
| Lot Number | E7UL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEWDEAL |
| Manufacturer Address | LYON 69006 FR 69006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-30 |