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 2018-03-28 for 95 DEG CONDYLAR PLATE 9 HOLES/80MM/156MM 237.960 manufactured by Oberdorf Synthes Produktions Gmbh.
[103702922]
Height of the patient is reported as 172 cms. Patient? S identifier is not provided for reporting. Date of postoperative plate breakage is unknown. (b)(4) used to capture additional medical/surgical intervention required. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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
[103702923]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that post-operatively a condylar plate broke. The plate was implanted on (b)(6) 2017 and patient was revised on (b)(6) 2018. Concomitant devices reported: cortscr? 4. 5 self-tap l42 sst (part # 214. 842, lot # 99152688, quantity 1), cortscr? 4. 5 self-tap l36 sst (part # 214. 836, lot # l067948, quantity 1), cortscr? 4. 5 self-tap l36 sst (part # 214. 836, lot # l121493, quantity 1), cortscr? 4. 5 self-tap l48 sst (part # 214. 848, lot # 9886958, qty 1), 6. 5mm cancellous bone screw fully threaded/75mm (part # 218. 075, lot # 1077, quantity 1), unknown screws (part # unknown, lot # 1137, quantity 1). This report is for one (1) 95 deg condylar plate 9 holes/80mm/156mm. This is report 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-52513 |
| MDR Report Key | 7377742 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-02 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2005-04-08 |
| Date Added to Maude | 2018-03-28 |
| 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 GRENCHEN (CH) |
| Manufacturer Street | SOLOTHURNSTRASSE 186 |
| Manufacturer City | GRENCHEN 2540 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2540 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 95 DEG CONDYLAR PLATE 9 HOLES/80MM/156MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-03-28 |
| Returned To Mfg | 2018-03-12 |
| Catalog Number | 237.960 |
| Lot Number | 2128937 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-28 |