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 2018-09-12 for SYNMESH? 15MM DIA 32MM HEIGHT (TI) 495.365 manufactured by Oberdorf Synthes Produktions Gmbh.
[120001675]
Patient? S weight was not provided for reporting. Date of event is unknown. Additional device product code: mqp. Device remained implanted. Explant date is not applicable. Device is not expected to be returned for manufacturer review/investigation. (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review has been requested. 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
[120001676]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent a cervical corpectomy. Patient was implanted with one synmesh cage, two end rings (associated with segment arthrodesis), one vectra titanium (2-level) plate, and four 4. 0mm titanium cervical spine screws. Post-operative, patient experienced implant pull out of the 18mm screws. The failure of the fixation was detected on (b)(6) 2018. Symptoms presented in the postoperative period was mild dysphonia. Due to high instability and risk of spinal cord injury, the patient underwent a revision surgery on (b)(6) 2018. During the revision, surgeon removed the vectra plate and screws, repositioned the implants synmesh and placed another non-synthes system consisting of an anterior plate and cervical screws. After the procedure, it was noted that the fixation was not satisfactory, and the patient was revised on (b)(6) 2018 for complementation of cervical fixation posteriorly. During the surgery, lateral bone screws (axon depuy system) were placed on the vertebrae c5-c6-c7 vertebrae. Postoperatively, approximately around (b)(6) 2018 patient was noted to be still dysphonic but with cervical stability. Review of provided images by manufacturer noted that the lower two screws have pulled out allowing the plate to anteriorly pull away from the bone in the lower vertebral body and thus the cage has also dislodged anteriorly. Concomitant devices reported: 4. 0mm titanium cervical self-retaining screw self-drilling variable angle 18mm (part # 04. 613. 518, lot # 7537445, quantity 2); end ring 15mm diameter/ 0 degree titanium (part # 495. 386, lot # 7882139, quantity 2). This report is for one (1) synmesh? 15mm dia 32mm height (ti). This is report 3 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-56281 |
| MDR Report Key | 7870189 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-12 |
| Date of Report | 2018-08-15 |
| Date Mfgr Received | 2018-10-22 |
| Device Manufacturer Date | 2016-08-16 |
| Date Added to Maude | 2018-09-12 |
| 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 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNMESH? 15MM DIA 32MM HEIGHT (TI) |
| Generic Name | SURGICAL MESH |
| Product Code | EZX |
| Date Received | 2018-09-12 |
| Model Number | 495.365 |
| Catalog Number | 495.365 |
| Lot Number | H168354 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-12 |