MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT; IMPLANT,FIXATION DEVICE,CONDYLAR PLATE

Model Number	02.124.416
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date device bent is not known.Date of implant is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4) -no code available used to capture required intervention.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.
Event or Problem Description
It was reported that a patient underwent revision of one (1) 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate, six (6) locking screws and two (2) non-locking screws on (b)(6) 2018 due to a bent plate.The entire construct revised was implanted on an unknown date.Subsequently, due to the patient being non-compliant, the plate bent but did not break.Surgeon revised the patient to an unknown plate and screws construct.The revision surgery was completed successfully.Patient condition after the surgery is unknown.Concomitant devices reported: locking screws (part number unknown, lot number unknown, quantity 6); non-locking screws (part number unknown, lot number unknown, quantity 2).This report is for one (1) 4.5mm va-lcp curved condylar plate.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• Common Device Name: IMPLANT,FIXATION DEVICE,CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7438465
• Report Number: 2939274-2018-51790
• Device Sequence Number: 13739899
• Product Code: JDP
• UDI-Device Identifier: 10886982042934
• UDI-Public: (01)10886982042934
• Combination Product (Y/N): N
• Initial Reporter State: MO
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.124.416
• Device Catalogue Number: 02.124.416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention