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 2018-09-26 for LCP DHS-PL 135? 4HO L92 STANDBARREL SST 02.224.224S manufactured by Oberdorf Synthes Produktions Gmbh.
[121860942]
Patient information is not available for reporting. Due to the intra-operative events, the device was not successfully implanted. An alternate device was used to complete procedural step. As such, implant/explant dates are not applicable. Device is not distributed in the united states, but is similar to device marketed in the usa. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A device history record review has been requested. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10
[121860943]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during implanting the lag screw, it did not fit into the dynamic hip plate (dhs). The customer took out the lag screw and tested it on a new plate. It appeared that the problem was the lag screw because it didn't fit. There was a 20 minute delay but no harm to patient. Procedure; proximal femur / hip fracture using dynamic hip system (dhs). This complaint involves one (1) lcp dhs plate. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-56678 |
| MDR Report Key | 7910435 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-03 |
| Date of Event | 2018-09-02 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2018-04-26 |
| Date Added to Maude | 2018-09-26 |
| 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 | MR. 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 GRENCHEN (CH) |
| Manufacturer Street | SOLOTHURNSTRASSE 186 |
| Manufacturer City | GRENCHEN 2540 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2540 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LCP DHS-PL 135? 4HO L92 STANDBARREL SST |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-09-26 |
| Returned To Mfg | 2018-09-18 |
| Catalog Number | 02.224.224S |
| Lot Number | L832015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-09-26 |