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 2020-02-21 for 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE 852.421.01S manufactured by Wrights Lane Synthes Usa Products Llc.
[181545967]
Date of event: event date is not recognizable complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; 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
[181545968]
It was reported that on february 1, 2020, the patient had cranial vault reconstruction surgery on (b)(6) 2020, it was further reported after incision/exposure of the affected area it was determined that the plate that buckled was not the 1. 5mm resorbable strut plate 2x36 holes, but instead a 2. 0mm resorbable strut plate 2x18 holes with 2. 0mm resorbable cortex screws eight (8) each. Specific lot numbers for the plate or screws cannot be identified since there was more than one lot number used for each. The gap in the bone that plate spanned was 15mm. Upon removal of the affected plate/screws, the wound was debrided, irrigated, and closed. There was no surgical delay reported. The procedure was successfully completed. The patient was stable after the procedure. This is report 01 of 03 of (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00998 |
| MDR Report Key | 9741874 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-21 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-02-21 |
| 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 | 2020-02-21 |
| 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 | 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 | 2020-02-21 |