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 2020-03-04 for . MATRIXMANDIBLE SHORT CUT . PLATE CUTTER 03.503.057 manufactured by Oberdorf Synthes Produktions Gmbh.
[188256024]
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188256025]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date that 1 of 2 shortcut for matrix mandible plate cutters are broke in half whilst cutting the plate. An old shortcut plate cutter from a 2. 4 unilock set was substituted and cut the plate fine. There was no reported delay. The procedure was completed successfully. There was no patient consequence. Concomitant devices reported: unknown plate (part# unknown, lot# unknown, quantity# 1). This is 1 of 1 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-01648 |
| MDR Report Key | 9788134 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-08 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-04 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | . MATRIXMANDIBLE SHORT CUT . PLATE CUTTER |
| Generic Name | INSTRUMENT,CUTTING,ORTHOPAEDIC |
| Product Code | HTZ |
| Date Received | 2020-03-04 |
| Catalog Number | 03.503.057 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-04 |