MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI PATIENT SPECIFIC PLATE MANDIBLE/ANGLE/2.0MM THICK; BONE PLATE

Model Number	SD480.110
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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.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 on (b)(6) 2019, the patient underwent mandible resection.The plate and screws were placed, and a titanium patient specific plate mandible was removed.The patient was noted to have poor bone quality.There was no malfunction of the plate or screws.The patient had a fracture around the plate and screws and probable osteomyelitis.Only the bone around the hardware failed.It is unknown if there was surgical delay.Procedure and patient outcome are unknown.This report is for one (1) ti patient specific plate mandible/angle/2.0mm thick.This is report 1 of 2 for (b)(4).

• Brand Name: TI PATIENT SPECIFIC PLATE MANDIBLE/ANGLE/2.0MM 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: 8382490
• Report Number: 2939274-2019-56752
• Device Sequence Number: 1827854
• Product Code: JEY
• UDI-Device Identifier: 10887587005324
• UDI-Public: (01)10887587005324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: SD480.110
• Device Catalogue Number: SD480.110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention