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 2018-06-20 for 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM 241.901 manufactured by Wrights Lane Synthes Usa Products Llc.
[111742213]
Complainant part 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. A review of the device history records 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
[111742214]
It was reported that on (b)(6) 2018, the patient underwent revision surgery. The locking compression plate (lcp) proximal humerus plate, three (3) locking screws, and three (3) cortex screws were removed. This was due to the patient falling and re-breaking the arm on (b)(6) 2018. The original implant date was (b)(6) 2018. There was no reported failure of the plate and screws. The devices were removed successfully without any issues. There was no patient consequence and no surgical delay reported. This is report 1 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52562 |
| MDR Report Key | 7621085 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-20 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2010-05-21 |
| Date Added to Maude | 2018-06-20 |
| 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 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 | 2018-06-20 |
| Model Number | 241.901 |
| Catalog Number | 241.901 |
| Lot Number | 3438435 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-06-20 |