MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PL/LEFT/2.5MM; BONE PLATE

Model Number	SD449.510B
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter phone number is not provided for reporting.A device history record (dhr) review was performed for part # sd449.510b, lot # h484752: manufacturing site: (b)(4), manufacturing date: 19-oct-2017: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a surgery on (b)(6) 2017, a surgeon didn't find the whole mandible kit to be properly functional.The titanium (ti) pspc matrixmandible 7x23h angle recon plate/left/2.5 mm was bent to the model but not as per the standards.The surgeon had to re-bend the plate which caused almost 45 minutes to 1 hour of surgical delay.The planned outcome model mandible, clear didn't sit right.Also, the appearance of the anatomical model specialty/medium/clear was not as per the surgeon's requirements.The surgery was completed with stable patient outcome.This report is for one (1) ti pspc matrixmandible 7x23h angle recon pl/left/2.5 mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TI PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PL/LEFT/2.5MM
• Common Device Name: BONE PLATE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 7037194
• Report Number: 2530088-2017-10338
• Device Sequence Number: 939535
• Product Code: JEY
• UDI-Device Identifier: 10887587004747
• UDI-Public: (01)10887587004747(10)H484752
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD449.510B
• Device Catalogue Number: SD449.510B
• Device Lot Number: H484752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/16/2017
• Patient Sequence Number: 1