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 2018-02-22 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Oberdorf Synthes Produktions Gmbh.
[100764519]
Patient information is not available for reporting. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter phone number is not provided. 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
[100764520]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during an unknown surgery performed on (b)(6) 2018 the two teeth of the shaft for trephine attachments have broken off into the patient. The teeth retained in the patient. The patient has been made aware of it and the hospital are monitoring the patient. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-51328 |
| MDR Report Key | 7290048 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-01-11 |
| Date Mfgr Received | 2018-04-11 |
| Date Added to Maude | 2018-02-22 |
| 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 | MR. 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 | SHAFT FOR TREPHINE ATTACHMENTS |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2018-02-22 |
| Catalog Number | 03.111.030 |
| Lot Number | L439154 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2018-02-22 |