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 2020-02-24 for 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE 852.421.01S manufactured by Wrights Lane Synthes Usa Products Llc.
[181809394]
Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(4). 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
[181809395]
It was reported that on (b)(6) 2020 the patient had a cranial vault reconstruction surgery. The patient was taken back to the on (b)(6) 2020 for removal of the affected plate. After the incision/ exposure of the affected area it was determined that the plate that buckled was not the 1. 5mm resorbable strut plate 2 x 36 holes (851. 436. 01s), but instead a 2. 0mm resorbable strut plate 2 x 18 holes (852. 421. 01s) with 2. 0mm resorbable cortex screws (8 ea) (806. 004. 10s). The gap in the bone that plate spanned was 15mm. The surgeon used a periosteal elevator to pry the plate off of the bone for removal and as a result he broke the plate in half and sheared the screws. Upon removal of the affected plate/ screws the wound was debrided, irrigated, and closed. It is unknown if there was a surgical delay. The procedure and patient status is unknown. This report is for one 2. 0mm rapid resorbable strut plate 2 holesx18 holes-sterile. This is report 1 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01007 |
| MDR Report Key | 9744167 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-01 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-04-01 |
| Date Added to Maude | 2020-02-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE |
| Generic Name | BONE PLATE |
| Product Code | JEY |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-13 |
| Model Number | 852.421.01S |
| Catalog Number | 852.421.01S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-24 |