MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-04 for 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM 241.901 manufactured by Oberdorf Synthes Produktions Gmbh.
[93682679]
Complainant device is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[93682680]
It was reported that the patient underwent revision of a plate and eight screws on (b)(6) 2017 due to malunion and nonunion. The 3. 5mm locking compression plate (lcp) proximal humerus plate and screws were originally implanted on an unknown date. The procedure included implantation of multiloc humeral nail + ria bone graft harvest from left femur & application. The procedure was successfully completed with no delay. The patient outcome was as planned. This report is for one (1) 3. 5mm lcp proximal humerus plate-standard 3h shaft/90mm. This is report 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[115259652]
A device history record review was performed for the subject device lot no. : 9841460. Manufacturing location: (b)(4). Release to warehouse date: 02. Mar. 2016. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A product development investigation was performed for the subject device: a 3. 5mm lcp proximal humerus plate (part 241. 901
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2017-50268 |
| MDR Report Key | 7080486 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-04 |
| Date of Report | 2017-11-06 |
| Date Mfgr Received | 2018-01-03 |
| Device Manufacturer Date | 2016-03-02 |
| Date Added to Maude | 2017-12-04 |
| 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 BIO OBERDORF (CH) |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2017-12-04 |
| Model Number | 241.901 |
| Catalog Number | 241.901 |
| Lot Number | 9841460 |
| 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 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-04 |