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

Model Number	25-772-11-91
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The locking screw sheared off as it was being torqued in.Broke at the bone level and was left in the patient.No other issues.The rest of the plate was fixated without complication.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the returned product.Tensile cracks were observed under the stereo microscope.Further investigation determined that there was no indication of material or manufacturing defects observed.The product device history records were also reviewed based on the lot number provided, and no anomalies were found.The results of the investigation have concluded that the root cause for the breakage was 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: 6449192
• Report Number: 9610905-2017-00037
• Device Sequence Number: 13608422
• Product Code: MQN
• UDI-Device Identifier: 00888118045744
• UDI-Public: (01)00888118045744
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K032442
• 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): 03/05/2017

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: 25-772-11-91
• Device Lot Number: 33172716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2017
• Supplement Date Received by Manufacturer: 03/05/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 09/08/2017
• 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: 22 YR