MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG CRANIAL DISTRACTOR

Model Number	51-405-42-09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Tip of the distractor broke off at where the activation arm was attached to while the patient asleep.
Additional Manufacturer Narrative
Methods: visual inspection, stereo microscopic inspection.Results: tensile cracks were observed under the stereo microscope.There were no indications of material or manufacturing defects observed.The device history records could not be reviewed since no lot number was provided by the reporter.Assessment conclusion: 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 investigated report, an additional follow-up report will be submitted.

• Brand Name: CRANIAL DISTRACTOR
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 5762266
• Report Number: 9610905-2016-00025
• Device Sequence Number: 13453544
• Product Code: MQN
• UDI-Device Identifier: 00888118080868
• UDI-Public: (01)00888118080868
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2016

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: Health Professional
• Device Model Number: 51-405-42-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 08/19/2016
• 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