MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE MINI PL-TENSION BAND NARROW/2X2H/1.0MM THICK; BONE PLATE

Model Number	04.503.702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of plate breaking is unknown.Lot number is unknown.Date of implantation 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).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 revision surgery occurred on (b)(6) 2018 due to plate failure.A matrix mandible mini plate was removed due to device breakage.It is unknown if fragments were generated and removed.It was further noted that the patient had cancer and the mandible had been originally split to address the cancer.It was noted that there was an issue with a tooth which may have caused pressure on the plate.The revision procedure was completed successfully.It is unknown what the patient was revised to.Surgical delay and patient status are unknown.Concomitant devices: screws (part: unknown, lot: unknown, quantity: unknown).This report is for a matrixmandible mini pl-tension band narrow/2x2h/1.0mm thick.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE MINI PL-TENSION BAND NARROW/2X2H/1.0MM THICK
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7558245
• Report Number: 2939274-2018-52364
• Device Sequence Number: 1638086
• Product Code: JEY
• UDI-Device Identifier: 10887587022536
• UDI-Public: (01)10887587022536
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K063790
• 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): 05/10/2018

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: 04.503.702
• Device Catalogue Number: 04.503.702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/31/2018
• 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
• Patient Age: 47 YR
• Patient Weight: 80