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

Model Number	50-761-26-09
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
Plate broke after it was implanted and was removed and replaced.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the broken plate returned.Process evaluation was also performed based off the lot number provided.The stereo microscope investigation revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.A review of the product device history files was performed based on the lot number provided.No discrepancies were found in this investigation.The results of the investigation have concluded that the root cause for breakages was due to mechanical overload on the device.

• Brand Name: LEVEL ONE CMF
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6579058
• Report Number: 9610905-2017-00042
• Device Sequence Number: 90234
• Product Code: MQN
• UDI-Device Identifier: 00888118078292
• UDI-Public: (01)00888118078292
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/19/2017
• Report Date (Section F): 04/19/2017

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: 50-761-26-09
• Device Lot Number: 32958082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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: 59 YR