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 2019-03-12 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/RT-STER 02.124.416S manufactured by Oberdorf Synthes Produktions Gmbh.
[138521131]
Additional procodes: hrs, hwc. Date of implantation is reported to be an unknown date in late (b)(6) 2018. Complainant part is not expected to be returned for manufacturer review/investigation. Date of concomitant therapy is the same as date of implantation, an unknown date in late (b)(6) 2018. Reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(4). 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
[138521132]
Device report from the united kingdom reports an event as follows: it was reported that during a fixation of the distal femur in (b)(6) 2018, the patient was implanted with one (1) variable angle (va) locking compression plate (lcp) condylar plate, three (3) stardrive va locking screws, and two (2) self-tapping cortex screws. About 6-7 weeks ago, the plate started to bend. This was confirmed on x-ray on an unknown date. The patient has been weight bearing on the leg. There are currently no plans for revision. Concomitant devices: cortex screw (part: 214. 848s, lot: l430555, quantity: 1); cortex screw (part: 214. 836s, lot: l967243, quantity: 1); va locking screw (part: 02. 231. 275s, lot: 1l82474, quantity: 1); va locking screw (part: 02. 231. 275s, lot: 2l13298, quantity: 1); va locking screw (part: 02. 231. 280s, lot: l648063, quantity: 1). This report is for a 4. 5mm va-lcp curved condylar plate. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-61892 |
| MDR Report Key | 8412056 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-12 |
| Date of Report | 2019-02-25 |
| Date Mfgr Received | 2019-03-25 |
| Device Manufacturer Date | 2018-09-11 |
| Date Added to Maude | 2019-03-12 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK MEZZOVICO (CH) |
| Manufacturer Street | VIA CAVAZZ 5 |
| Manufacturer City | MEZZOVICO 6805 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/RT-STER |
| Generic Name | IMPLANT, FIXATION DEVICE, CONDYLAR PLATE |
| Product Code | JDP |
| Date Received | 2019-03-12 |
| Catalog Number | 02.124.416S |
| Lot Number | 1L24619 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2019-03-12 |