MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG DISTRACTION, INTERNAL; DISTRACTOR

Model Number	51-563-30-09
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	12/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient fell onto a tile floor and the impact broke the most distal cranial vault distractor where the body welds to the footplate.Patient wasn't injured but due to the device breaking the family traveled back to the hospital to have it looked at.The clinical decision was to have the distractor removed and replaced.The same stock number was used to replace the distractor.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the distractor returned.Process evaluation was also completed on the lot number provided.Tensile cracks were observed under the stereo microscope.It was determined there were no indications of material or manufacturing defects.The review of the product device history records was performed on the lot number provided.In this investigation no anomalies were discovered.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 will be submitted.

• Brand Name: DISTRACTION, INTERNAL
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6282364
• Report Number: 9610905-2017-00017
• Device Sequence Number: 11138635
• Product Code: MQN
• UDI-Device Identifier: 00888118082145
• UDI-Public: (01)00888118082145
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/28/2016

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: Physician
• Device Model Number: 51-563-30-09
• Device Lot Number: 33181807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2017
• 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: 3 YR