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

Device Problems Fracture (1260); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 08/17/2017

Event Type  malfunction  

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 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
• Type of Device: BONE PLATE
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anton mittermueller ; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8217500
• MDR Text Key: 132426499
• Report Number: 8010099-2019-00001
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 04046826318963
• UDI-Public: 4046826318963
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K951690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 68.74.14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR