MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2014-12-01 for SUBTALAR CBS SYS 7.5 C SINK CANN AO 80MM 503004350 manufactured by Normed Medizin-technik Gmbh.
[5131527]
It was reported that during the kit inspection rust was detected on a subtalar cbs sys 7. 5 sink cann ao 80mm on (b)(6) 2014 after return of the hospitals. It was also reported that there was already a black shine on the instruments at the operation.
Patient Sequence No: 1, Text Type: D, B5
[12658016]
The mfr received the device for investigation on november 20 2014. The investigation is pending. Pictures of the device were received for review. As the lot number of the instrument is unreadable due to rust, it is not possible to check the dhr at the moment. A cause for this specific event cannot be ascertained from the info provided. Should additional info become available and an investigation result be available that changes this assessment, an amended med device report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2014-04162 |
| MDR Report Key | 4308607 |
| Report Source | 00,01 |
| Date Received | 2014-12-01 |
| Date of Report | 2014-11-12 |
| Date of Event | 2014-11-12 |
| Date Mfgr Received | 2014-11-12 |
| Date Added to Maude | 2014-12-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 46581-070 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581-0708 |
| Manufacturer Phone | 5742676 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBTALAR CBS SYS 7.5 C SINK CANN AO 80MM |
| Generic Name | BURR, ORTHOPEDIC |
| Product Code | HTT |
| Date Received | 2014-12-01 |
| Returned To Mfg | 2014-11-20 |
| Model Number | NA |
| Catalog Number | 503004350 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORMED MEDIZIN-TECHNIK GMBH |
| Manufacturer Address | ULRICHSTRASSE 7 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-01 |