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 2018-08-01 for 130 DEG ANGLED BLADE PLATE 12 HOLES/90MM/200MM 238.280 manufactured by Oberdorf Synthes Produktions Gmbh.
[115712486]
Device is not expected to be returned for manufacturer review/investigation. Patient code (b)(4) used to capture additional medical/surgical intervention required. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device history records review has been requested. 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
[115712487]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on an unknown date in 2015, the patient initially sustained a left subtrochanteric proximal femur fracture and was primarily fixed with an smith and nephew (snn) nail. The patient underwent first revision surgery three (3) months post primary due to broken smith and nephew nail and was replaced with the same nail (non-synthes products were used). On an unknown date, the patient underwent second revision due to non-union and attempted to revise it with a locking compression plate (lcp) proximal femur plate and it was not completed as per technique guide with screws not fully locked into the plate. It continued to be non-united and developed low grade infection. On (b)(6) 2017, the patient underwent third revision wherein the low-grade infection and non-union where debrided and refixed with a 130-degree angle blade plate. On (b)(6) 2018, the patient underwent fourth revision surgery, an open reduction internal fixation (orif) of the proximal femur, due to broken 130-degree angle blade plate, fracture non-union and low-grade infection. One (1) 130-degree angle blade plate and eight (8) cortex screws were removed and replaced with a 95-degree angle blade plate and two (2) lag screws. The procedure was successfully completed. There was no surgical delay reported. Patient outcome was reported as stable. This (b)(4) will capture the fourth revision due to 130-degree angle blade plate had broken, fracture non-union and low-grade infection. (b)(4) captures the screws not fully locked into the lcp proximal femur plate which was not successfully completed which is supposedly the second revision. This report is for one (1) 130 deg angled blade plate 12 holes/90mm/200mm. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-55414 |
| MDR Report Key | 7739669 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-16 |
| Date Mfgr Received | 2018-10-10 |
| Device Manufacturer Date | 2010-09-29 |
| Date Added to Maude | 2018-08-01 |
| 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 WRIGHT 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 | 130 DEG ANGLED BLADE PLATE 12 HOLES/90MM/200MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-08-01 |
| Catalog Number | 238.280 |
| Lot Number | 2644065 |
| 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 | 1. Required No Informationntervention | 2018-08-01 |