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 2018-08-08 for TI MATRIXNEURO SCREW SELF-DRILLING 5MM 04.503.105.04S manufactured by Oberdorf Synthes Produktions Gmbh.
[116395924]
Additional procodes: gxr, jey. Device malfunctioned intra-operatively and was not implanted / explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. A 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
[116395925]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: the customer reports that during a cranial closure procedure on (b)(6) 2018, the screw thread blocked in the bone and the screw head broke. A second screw also broke in the same manner. All fragments were removed from the patient. The surgeon used other screws to complete the procedure. There was no surgical delay and no consequences for the patient. This report is for a titanium (ti) matrixneuro screw self-drilling 5mm. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-55544 |
| MDR Report Key | 7761766 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-08 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-06-27 |
| Date Mfgr Received | 2018-09-11 |
| Device Manufacturer Date | 2015-04-10 |
| Date Added to Maude | 2018-08-08 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI MATRIXNEURO SCREW SELF-DRILLING 5MM |
| Generic Name | PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE |
| Product Code | GWO |
| Date Received | 2018-08-08 |
| Catalog Number | 04.503.105.04S |
| Lot Number | 9437898 |
| 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 | 2018-08-08 |