MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE THORACIC; STERNAL PLATE

Model Number	24-025-50-09
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's thoracic plate broke near the xiphoid and was explanted.The other implanted plates remained intact and allowed for healing.Patient presented co pain and rubbing.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscope inspection of the plate returned.Tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacturing defects.The device history records could not be reviewed since no lot number was provided.The results of the investigation conclude that the root cause for the 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 report will be submitted.

• Brand Name: LEVEL ONE THORACIC
• Common Device Name: STERNAL PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6230672
• Report Number: 9610905-2016-00062
• Device Sequence Number: 13643888
• Product Code: HRS
• UDI-Device Identifier: 00888118031891
• UDI-Public: (01)00888118031891
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• 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): 12/21/2016

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: Physician
• Device Model Number: 24-025-50-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 04/13/2017
• 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: 56 YR
• Patient Weight: 145