MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-10-24 for NUT manufactured by Synthes Usa.
[20739355]
Device report from (b)(4) reports an event in (b)(6) as follows: patient underwent removal of rods and screws - t12-s1. Revision fusion, repair pseudoarthrosis l3-l4. Re-instrumentation t12-pelvis on (b)(6) 2010. This is #6 of 44 reports for the same event.
Patient Sequence No: 1, Text Type: D, B5
[20909800]
Additional narrative: device was used for treatment. Report originally received (b)(4) 2012; further evaluation revealed 43 additional devices within the reported event which were identified on (b)(4) 2012. Investigation could not be completed, no conclusion could be drawn as device was not returned and lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-02516 |
| MDR Report Key | 2802592 |
| Report Source | 01,07 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-08-29 |
| Date Mfgr Received | 2012-08-29 |
| Date Added to Maude | 2012-10-24 |
| 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 | SARMA PIN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NUT |
| Product Code | LYT |
| Date Received | 2012-10-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-24 |