MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,07 report with the FDA on 2013-02-27 for SPINE manufactured by Synthes.
[3129628]
Patient 4, it was reported that the spacer has moved. This is no additional information available.
Patient Sequence No: 1, Text Type: D, B5
[10507093]
Without lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
[30713544]
Device was used for treatment, not diagnosis. Upon further review, it was noted that this complaint #(b)(4), mfr report #2520274-2013-01210 is a duplicate filing for complaint #(b)(4), mfr report #2520274-2013-01211. Synthes usa is retracting mfr report #2520274-2013-01210. Mfr report #2520274-2013-01211 will remain on file.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-01210 |
| MDR Report Key | 2981352 |
| Report Source | 01,02,05,07 |
| Date Received | 2013-02-27 |
| Date of Report | 2011-07-25 |
| Date Mfgr Received | 2014-01-29 |
| Date Added to Maude | 2013-05-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | P NEAL |
| 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 |
| Brand Name | SPINE |
| Product Code | LYQ |
| Date Received | 2013-02-27 |
| Catalog Number | SPINE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 13980 13980 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-27 |