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

Model Number	25-882-07-91
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
Patient underwent a scapular free flap mandible reconstruction on (b)(6) 2017.The doctor reported the flap healed and bone was consolidated however some of the screws were no longer engaged in the bone.Patient underwent a secondary surgery to remove the hardware.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the distractor that was returned.Process evaluation was also completed on the lot number provided.Tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacturing defects observed.The product history device records were also reviewed based on the lot number provided, and no abnormalities were found.The results of the investigation conclude that the root cause for 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.
Additional Manufacturer Narrative
An investigation was performed based on complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.The product device history records were also reviewed based on the lot number provided, and no anomalies were found.The root cause for the failure cannot be determined due to no device being returned.If further information is obtained that might add value to the contents of the investigation report, and 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: 6489458
• Report Number: 9610905-2017-00056
• Device Sequence Number: 57539
• Product Code: MQN
• UDI-Device Identifier: 00888118047854
• UDI-Public: (01)00888118047854
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 06/05/2017
• Report Date (Section F): 06/05/2017

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: 25-882-07-91
• Device Lot Number: 33159408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/05/2017; 09/21/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 04/13/2017; 11/17/2017
• 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