MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-24 for manufactured by Synthes (usa) West Chester, Pa.
[3257137]
A presentation of the noteworthy radiographic observations of patients treated with synthes nflex implants reported that there was a suspected unknown quantity of screw loosening for patient id (b)(6) at the s1 location. The 3 month post op x-ray image shows that s1 is stabilized and motion between l5 and s1 is observed. There is also apparent toggling of the graft from flexion to extension consistent with toggling of the s1 screws within the bone. At the l2-3 treated level, there appears to be little or motion. Overall, the construct appears to be acting like a 4-level fusion. This mdr is one of three for this complaint, two for unk screws and one for unk graft. This report is for the unk graft. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[10608170]
Device was used for treatment. Actual event date not known. Exact part number could not be identified. The device is not being returned for evaluation. As no lot number was provided, no device history record review can be performed. There is no further information available on this event and no further investigation can be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-01673 |
| MDR Report Key | 3018731 |
| Report Source | 07 |
| Date Received | 2013-03-24 |
| Date of Report | 2008-08-28 |
| Date Mfgr Received | 2008-08-28 |
| Date Added to Maude | 2013-05-23 |
| 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 | T. MCCARRON |
| 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 |
| Product Code | MCV |
| Date Received | 2013-03-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) WEST CHESTER, PA |
| Manufacturer Address | PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-24 |