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

Model Number	25-872-15-91
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
While tightening the screw into the plate the screw head broke off and remained attached to the screwdriver blade.The shaft of the screw remains in the patient's mandible.
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 investigation determined that there was no indication of material or manufacturing defects observed.A review of the product device history files was performed based on the lot number provided.No discrepancies were found in this investigation.The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload.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 CMF
• Common Device Name: LEVEL ONE CMF
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6822438
• Report Number: 9610905-2017-00069
• Device Sequence Number: 19190221
• Product Code: JEY
• UDI-Device Identifier: 00888118046819
• UDI-Public: (01)00888118046819
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017
• Report Date (Section F): 07/27/2017

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: 25-872-15-91
• Device Lot Number: 32469340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 08/25/2017
• 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