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

Model Number	51-564-30-09
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial distractor was implanted into a pediatric patient.The patient's parent attempted to remove the activation arm and broke the distractor.The surgeon instructed them not to attempt to remove the activation arm or cardanic extension again to avoid another breakage of device.The patient underwent a secondary surgery to replace the broken device.
Additional Manufacturer Narrative
The device was optically assessed and stereo microscopically investigated in the lab.The stereo microscopic investigation revealed a tensile crack due to mechanical overload.Further observation determined there were no indications of material or manufacturing defects discovered.The product history device records were also reviewed based on the lot number provided and revealed no abnormalities.The results of the investigation conclude that the root cause for breakage was 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: 5662622
• Report Number: 9610905-2016-00015
• Device Sequence Number: 350796
• Product Code: MQN
• UDI-Device Identifier: 00888118082183
• UDI-Public: (01)00888118082183
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/27/2016

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: 51-564-30-09
• Device Lot Number: 33136271
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 07/27/2016
• 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
• Patient Age: 3 YR