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

Model Number	25-872-11-91
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During implantation of the screw the head of the screw broke off.Doctor attempted to remove the screw but with no success.Doctor chose to leave the screw in the patient.The screw was 9/10 of the way in and was flush with the bone.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscope inspection of the screw head returned.Tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacturing defects.The device lot number was not provided by the customer therefore the device history records could not be reviewed.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 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: 6335646
• Report Number: 9610905-2017-00013
• Device Sequence Number: 1518449
• Product Code: JEY
• UDI-Device Identifier: 00888118046772
• UDI-Public: (01)00888118046772
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/18/2017

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: 25-872-11-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 06/12/2017
• 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: 32 YR