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 2017-12-15 for PFNA-II BLADE L95 TAN 04.027.054S manufactured by Oberdorf : Synthes Produktions Gmbh.
[95050114]
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. The manufacture date is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. Patient code: revision surgery is planned. 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
[95050115]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: the reported devices were used in the surgery for the femoral trochanter fracture on (b)(6) 2017. The patient was followed up for two months after the surgery. Thereafter, for some reasons, the patient could not be followed. When the patient was seen in the orthopedic outpatient service for a different reason on (b)(6), it was found that there had been a femoral head perforation. The removal surgery is planned. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2017-50771 |
| MDR Report Key | 7123580 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-15 |
| Date of Report | 2017-11-17 |
| Date Mfgr Received | 2018-02-15 |
| Date Added to Maude | 2017-12-15 |
| 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 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFNA-II BLADE L95 TAN |
| Generic Name | APPLIANCE,FIXATION,NAIL, PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2017-12-15 |
| Catalog Number | 04.027.054S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF : SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-15 |