MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-04-04 for ENDPLATE, LARGE, 3 1801-503 manufactured by Zimmer Spine.
[20857485]
Same case as: 2184052-2014-00059, 00057, 00056, 00054, 00055. It was reported that during surgery the surgeon had trouble implanting the infix implant. The first set of 8mm struts started to scissor, so they were put aside and the surgeon loaded two new 8mm struts in the guides. After trying to lock the construct the locker did not work. The surgeon looked and saw the 8mm struts had scissored and damaged the endplate. The surgeon used different sizes struts was able to successfully complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
[21165548]
Visual analysis of the returned device confirmed the reported event. Manufacturing records reviewed indicated no deviations or anomalies. It is not suspected that the product failed to meet specifications. The most probable root cause of this event was operational context as the device performance was limited by procedural/anatomical factors. The information contained herein is being provided to the fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may or may not be factually correct. This is the final report that will be submitted associated with this incident and device. No additional action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2014-00058 |
| MDR Report Key | 3808184 |
| Report Source | 08 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-03-06 |
| Date of Event | 2014-03-06 |
| Date Mfgr Received | 2014-03-06 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-06-02 |
| 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 | SCOTT LAPOINTE |
| Manufacturer Street | 7375 BUSH LAKE RD. |
| Manufacturer City | MINNEAPOLIS MN 55439 |
| Manufacturer Country | US |
| Manufacturer Postal | 55439 |
| Manufacturer Phone | 9528325600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDPLATE, LARGE, 3 |
| Generic Name | ENDPLATE, LARGE, 3 |
| Product Code | JDN |
| Date Received | 2014-04-04 |
| Returned To Mfg | 2014-03-12 |
| Model Number | 1801-503 |
| Catalog Number | 1801-503 |
| Lot Number | 78JZ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | 7375 BUSH LAKE RD. MINNEAPOLIS MN 55439 US 55439 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-04 |