MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG PCI PRE-BENT PLATE

Model Number	60-650-01-04
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Reconstruction plate broke.Patient was compliant however the doctor believes the patient might have grinded or clinched during the night causing stress.Plate was removed and replaced.
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.Tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacturing defects observed.The product history device records were also reviewed based on the lot number provided, and no abnormalities were found.The results of the investigation conclude that the root cause for breakages were 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 will be submitted.

• Brand Name: PCI PRE-BENT PLATE
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6191460
• Report Number: 9610905-2016-00057
• Device Sequence Number: 185273
• Product Code: MQN
• UDI-Device Identifier: 00888118095015
• UDI-Public: (01)00888118095015
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2016

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: No Information
• Device Model Number: 60-650-01-04
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 05/19/2017
• 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
• Patient Age: 64 YR