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 2020-03-27 for UNK - PLATES: SPINE UNK - PLATES: SPINE-US manufactured by Oberdorf Synthes Produktions Gmbh.
[186533711]
Product complaint # (b)(4). 510k: this report is for an unknown plate/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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 conclusion could be drawn at the time of filing this report. 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
[186533712]
Device report from synthes reports an event in (b)(6) as follows: it was reported that the doctor placed the guide in the hole of the plate and attempted to seat it. He had a little trouble doing this, however managed to seat the pin in the hole of the plate and placed 4 screws. As he lifted the guide out of the last place the pin got stuck and he had to remove the pin with forceps. Surgery was delayed due to the reported event five (5) minutes. Concomitant devices reported: unknown plate (part # unknown, lot # unknown, quantity # 1), unknown screws (part # unknown, lot # unknown, quantity # unknown). 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 | 8030965-2020-02353 |
| MDR Report Key | 9891071 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-01 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-01 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - PLATES: SPINE |
| Generic Name | PLATE, FIXATION, BONE |
| Product Code | HRS |
| Date Received | 2020-03-27 |
| Catalog Number | UNK - PLATES: SPINE-US |
| 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 | 2020-03-27 |