MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMANDIBLE 12 HOLE ADAPTION PL 1.0MM THICK; BONE PLATE

Model Number	04.503.705
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of postoperative plate breakage is unknown.Explanted date: unknown if the device has been explanted yet.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient was implanted with the a twelve-hole matrixmandible plate on (b)(6) 2018, as a revision to a prior broken four-hole matrixmandible plate.The twelve-hole matrixmandible plate also broke postoperatively on an unknown date.An x-ray taken on (b)(6) 2018 revealed the broken plate.The revision surgery schedule is still unknown.The patient consequences are unknown.This report addresses second revision surgery due to postoperative broken plate.The first revision surgery due to broken plate has been reported under linked complaint (b)(4).This report is for one (1) ti matrixmandible 12 hole adaption plate.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TI MATRIXMANDIBLE 12 HOLE ADAPTION PL 1.0MM THICK
• Common Device Name: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7782300
• Report Number: 8030965-2018-55713
• Device Sequence Number: 1757862
• Product Code: JEY
• UDI-Device Identifier: 10887587022567
• UDI-Public: (01)10887587022567
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2018

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: 04.503.705
• Device Catalogue Number: 04.503.705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2018
• Initial Report FDA Received Date: 08/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention