MAUDE Adverse Event Report: MEDICON E.G. TI MINI PLATE 4 HOLES SHORT INT SECT 8MM P/2; BONE PLATE

Catalog Number	68.74.14
Medical Device Problem Codes	Fracture (1260); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient x-rays were analyzed independently by two surgeons specialized in oral and maxillofacial surgery employed at different hospitals in (b)(6).Both state that considering the type of fracture and particularly the area of the mandible where it occurred, which is subject to the highest masticatory forces and movement, it would have been preferable to choose a more stable plate provided with a central bar rather than the ones used, which bend easily due to the small spaces between the holes and their reduced thickness of only 1 mm.The fractured plates initially chosen by the user would be more appropriate for the upper midface area that is hardly subject to any forces.A review of complaint history for this device for the last 13 years yielded no results; i.E., no complaints were received during this time period.Investigations are in progress.Should additional information become available, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2017 - two bone plates implanted in fractured mandible.On (b)(6) 2017 - control x-ray, bone plates intact.On (b)(6) 2017 - panoramic radiograph reveals fracture of the upper bone plate (plate #1, current mdr report).Patient experiencing pain.On (b)(6) 2017 - fracture of bone plate #2 is detected.On (b)(6) 2018 - both plates explanted.No alveolar fistula, no infection, no pathologic mobility.Consolidation fine.On (b)(6) 2018 - new, thicker 2-mm bone plates implanted.Signs of infection during follow-up.New plates intact.Standard postoperative protocol followed.

• Brand Name: TI MINI PLATE 4 HOLES SHORT INT SECT 8MM P/2
• Common Device Name: BONE PLATE
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8217500
• Report Number: 8010099-2019-00001
• Device Sequence Number: 334671
• Product Code: JEY
• UDI-Device Identifier: 04046826318963
• UDI-Public: 4046826318963
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K951690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 68.74.14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 01/04/2019
• 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: 34 YR