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

Model Number	25-872-07-91
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon was plating a left angle fracture when the screw head fractured off.The remainder of the screw is still in the patients mandible.There were no consequences to the patient besides the rest of the screw being left in the mandible.
Additional Manufacturer Narrative
Visual inspection by stereo microscope was performed.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 the lot number was provided by the reporter.The results of the investigation conclude that the root cause for breakages were due to mechanical overload on the device.If further information can be gathered that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE CMF
• Common Device Name: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6147379
• Report Number: 9610905-2016-00043
• Device Sequence Number: 407719
• Product Code: JEY
• UDI-Device Identifier: 00888118046734
• UDI-Public: (01)00888118046734
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K943347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

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: 25-872-07-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 02/03/2017
• 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: 23 YR