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 2020-02-17 for TI LOCKING CALCANEAL PLATE SHORT-RIGHT 441.622 manufactured by Oberdorf Synthes Produktions Gmbh.
[188236194]
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Pma/510k: 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
[188236195]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent for calcaneus plates - calcaneus surgery -when doctor begins with the molding of the plaque, and subtly performs it but plaque is fatigued. It was unknown if surgery completed successfully without delay. The patient outcome was unknown. This is report 01 of 01 of (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-01177 |
| MDR Report Key | 9717819 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-17 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-06-17 |
| Date Added to Maude | 2020-02-17 |
| 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 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 | TI LOCKING CALCANEAL PLATE SHORT-RIGHT |
| Generic Name | APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM |
| Product Code | LXT |
| Date Received | 2020-02-17 |
| Catalog Number | 441.622 |
| Lot Number | 4L96766 |
| 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 | 2020-02-17 |