MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for REDUC-FORC W/POINT SOFTLO L161 399.084 manufactured by Oberdorf Synthes Produktions Gmbh.
[130473774]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10
[130473775]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the ratchet part of a reduction forceps was broken. There is no patient involvement. 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 | 8030965-2018-58955 |
| MDR Report Key | 8156358 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-11-20 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2009-12-22 |
| Date Added to Maude | 2018-12-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES SALZBURG |
| Manufacturer Street | VORGARTENSTRASSE 206B |
| Manufacturer City | 1020WIEN |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 1020 WIEN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REDUC-FORC W/POINT SOFTLO L161 |
| Generic Name | FORCEPS, GENERAL & PLASTIC SURGERY |
| Product Code | GEN |
| Date Received | 2018-12-12 |
| Catalog Number | 399.084 |
| Lot Number | 5904295 |
| 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 | 2018-12-12 |