MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-04 for SYNMESH CORPECT DEVICE ?12 H18 TI 495.451 manufactured by Synthes Monument.
[71684636]
Device used for treatment, not diagnosis. (b)(4). Original implant date is unknown. Device is not expected to be returned for manufacturer review/investigation. (b)(6). (b)(4). Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[71684637]
It was reported that there was a revision surgery for c5 corpectomy and fusion was performed on (b)(6) 2017 by surgeon this was a revision procedure. Following the primary procedure, the plate (depuy parts)186801026 and 186864014 x 2 had pulled out of the c6 vertebral body (b)(6) percent. The inferior part of 495. 451 had also slipped anteriorly. In the primary procedure, the inferior part of the synmesh c was placed on the inferior endplate of the c5 vertebrae with the c5/6 disc below retained in addition. The synmesh c may have subsided. There was no identifiable issues with any of the implants upon removal. The revision was completed with a discectomy at c5/6 and c5 endplate removal at the level below and another synmesh c cage (rested on the inferior endplate of c4 and superior endplate of c6), skyline plate and screws were implanted. The plate was locked off as per the surgical technique. The surgeon was very pleased with the revision procedure. This case is not being reported by the customer, but (b)(6) employee. All available information has been provided as part of this report; no further information will be forthcoming. Depuy parts reported case file (b)(4). This complaint involves one part. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[81174291]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2017-10282 |
| MDR Report Key | 6457635 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-16 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-04-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNMESH CORPECT DEVICE ?12 H18 TI |
| Generic Name | SURGICAL MESH |
| Product Code | EZX |
| Date Received | 2017-04-04 |
| Catalog Number | 495.451 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-04 |