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 2020-02-07 for 3.5MM TI LCP? METAPHYSEAL PLATE 11 HOLES 423.411S manufactured by Wrights Lane Synthes Usa Products Llc.
[178170796]
Device is not distributed in the united states but is similar to device marketed in the usa. (b)(4). The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
[178170797]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a massive tumor resection surgery for malignant bone tumor with the lcp metaphysical plate. On an unknown date after the surgery, the plate was broke. On (b)(6) 2020, the patient underwent a re-operation in which the plate was replaced by another metaphyseal plate (11 holes) after the fibula bone was grafted into the medullary cavity of fracture site. Another lcp plate was also implanted to reinforce the fixation. There was no surgical delay. The patient outcome was unknown. Concomitant device reported: unk - screws: (part # unknown; lot # unknown; quantity: unknown). This is report 01 of 01 of (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00714 |
| MDR Report Key | 9682246 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-16 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2017-02-15 |
| Date Added to Maude | 2020-02-07 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| 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 | 3.5MM TI LCP? METAPHYSEAL PLATE 11 HOLES |
| Generic Name | APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM |
| Product Code | LXT |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2020-02-04 |
| Catalog Number | 423.411S |
| Lot Number | L296525 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-07 |