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 2018-05-15 for PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE manufactured by Oberdorf Synthes Produktions Gmbh.
[108286761]
Patient information is unknown. Device has not been explanted. This report is for an unknown matrixneuro screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter phone number and email address are unavailable. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[108286762]
Device report from synthes europe reports an event in the (b)(6) as follows: it was reported that the surgeon requested for the matrix system to reinsert the bone back to head. While the surgeon was screwing the bone and the plate the head of the screw come off from the tail. The surgeon tried another 4 screws and all the heads came off from the tails. They removed the system from the sterile field and used a different kit to continue the operation. The surgeon did try to remove the broken screws but he abandoned the attempt as he would have damaged the bone flap. There was no harm to the patient as the screws were being screwed into the hole on the plate on the scrub nurses trolley not in the patient? S head. Patient status is unknown. Concomitant devices: unknown matrixneuro plate (part/lot number: unknown, quantity 1). This report is for an unknown matrixneuro screw. This is report 5 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-53768 |
| MDR Report Key | 7514856 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-15 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-05-15 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE |
| Product Code | GWO |
| Date Received | 2018-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-05-15 |