MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-18 for UNIVERSAL PLATE BENDER 387.293 manufactured by Oberdorf Synthes Produktions Gmbh.
[124508844]
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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. A device history record review has been requested. Device is not distributed in the united states, but is similar to device marketed in the usa. 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
[124508845]
Device report from (b)(6) reports an event as follows: it was reported that a universal plate bender fell apart on an unknown date. It is unknown if there was a surgical procedure and patient involvement. Upon review of provided picture of the device, it was discovered that the screw of the plate bender is broken. This report is for a universal plate bender. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-57435 |
| MDR Report Key | 7980199 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-18 |
| Date of Report | 2018-09-28 |
| Date Mfgr Received | 2018-11-20 |
| Device Manufacturer Date | 2009-12-22 |
| Date Added to Maude | 2018-10-18 |
| 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 | 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 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNIVERSAL PLATE BENDER |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2018-10-18 |
| Returned To Mfg | 2018-11-02 |
| Catalog Number | 387.293 |
| Lot Number | T942659 |
| 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 | 2018-10-18 |