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 2017-11-30 for 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM 241.901 manufactured by Wrights Lane : Synthes Usa Products Llc.
[93350811]
Device was scheduled to be explanted on (b)(6) 2017. It is unknown if that procedure occurred as planned. : 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 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
[93350812]
Original surgery to treat a left proximal humerus fracture was performed on (b)(6) 2017. The patient was implanted with sixteen (16) synthes devices which include twelve (12) locking screws, three (3) cortex screws and one (1) plate. The patient returned on an unknown date for post-operative x-rays. The x-rays revealed non-union as the fracture did not heal as expected. It was also reported that the patient had fallen multiple times post-operatively and was non-complaint with post-operative care. To address the non-union, surgeon will be performing a revision for hardware removal on (b)(6) 2017. It has been decided that all of the 16 implanted devices will be removed. Patient will be revised to a different treatment plan and no new devices will be implanted; it is unknown if that procedure occurred as planned. There was no reported product problem and per the x-rays, the devices appeared to be intact. This is report 11 of 16 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2017-50081 |
| MDR Report Key | 7071073 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-30 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-10-31 |
| Date Added to Maude | 2017-11-30 |
| 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 G1 | WERK RARON (CH) |
| Manufacturer Street | KANALSTRASSE WEST 30 |
| Manufacturer City | RARON 3942 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 3942 |
| 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 | 2017-11-30 |
| Model Number | 241.901 |
| Catalog Number | 241.901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE : SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-30 |