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 2018-04-16 for 95 DEG CONDYLAR PLATE 18 HOLES/80MM/299MM-STERILE 237.86S manufactured by Wrights Lane Synthes Usa Products Llc.
[105567923]
Patient weight was not provided. Date of event is unknown. Date of implant is an unknown date in 2016. Device is not expected to be returned for manufacturer review/investigation. (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. 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
[105567924]
It was reported that a 95-degree condylar plate and nine 4. 5 mm cortical screws were originally implanted in 2016 due to an unknown reason. Subsequently, antibiotic beads were placed in the area approximately one year ago due to infection. Patient underwent a hardware removal on (b)(6) 2018 due to ongoing infection. It was the patient? S decision to have the hardware removed. The hardware was removed fully intact. Nothing untoward occurred during the removal procedure. The procedure was completed successfully with the patient in stable condition. There is no evidence that the explanted hardware was related to the ongoing infection. The reporter was not aware of any patient symptoms. This report is for one (1) 95 deg condylar plate 18 holes/80 mm/299 mm-sterile. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-51722 |
| MDR Report Key | 7433253 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-16 |
| Date of Report | 2018-03-26 |
| Date Mfgr Received | 2018-03-26 |
| Date Added to Maude | 2018-04-16 |
| 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 95 DEG CONDYLAR PLATE 18 HOLES/80MM/299MM-STERILE |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-04-16 |
| Model Number | 237.86S |
| Catalog Number | 237.86S |
| 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 | 2018-04-16 |