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 2018-04-04 for 130 DEG ANGLED BLADE PLATE 6 HOLES/80MM/104MM 283.66 manufactured by Oberdorf Synthes Produktions Gmbh.
[104410047]
Device used for treatment, not diagnosis. Date of event: unknown. 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. (b)(6). Device history records review was requested. 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
[104410048]
Device report from synthes on an event in (b)(6) as follows: it was reported that a patient was implanted with an angled blade for a left femoral proximal femoral osteotomy in (b)(6) 2017. In (b)(6) 2017, the patient suffered a fall, causing the blade to rupture. A new blade was implanted on (b)(6) 2017. Concomitant devices reported: screws (part # unknown, lot # unknown, quantity unknown). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-52782 |
| MDR Report Key | 7398016 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-04 |
| Date of Report | 2018-03-09 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2011-09-03 |
| Date Added to Maude | 2018-04-04 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA |
| Manufacturer Country | SZ |
| 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 | 130 DEG ANGLED BLADE PLATE 6 HOLES/80MM/104MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-04-04 |
| Model Number | 283.66 |
| Catalog Number | 283.66 |
| Lot Number | 2773089 |
| 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 | 2018-04-04 |