MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG PCI; PLATE

Model Number	60-660-01-04
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the plate began fracturing therefore event date could not be determined.(b)(4).Reference exemption number e2017029.
Event or Problem Description
Plate was implanted into the patient after a tumor resection of the jaw.After implantation plate fractured in half by the angle of the mandible.There was no trauma to the area and nothing that the doctor knew of that would have caused the break.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the plate that was returned.Process evaluation was also completed on the lot number provided.The stereo microscope investigation revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.The product device history records were also reviewed based on the lot number provided, and no anomalies were found.The results of the investigation have concluded that the root cause for breakage was due to mechanical overload on the device.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: PCI
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6593892
• Report Number: 9610905-2017-00046
• Device Sequence Number: 10782901
• Product Code: MQN
• UDI-Device Identifier: 00888118095022
• UDI-Public: (01)00888118095022
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K032442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017
• Report Date (Section F): 04/25/2017

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: Physician
• Device Model Number: 60-660-01-04
• Device Lot Number: 8304
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2017
• Date Report to Manufacturer: 04/25/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: Other