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

Model Number	51-405-42-09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Cranial vault distractor was in activation phase at 2 mm per day for 10 days when one distractor "stopped clicking".Implant was evaluated, cleaned and felt to be working.Distraction continued for 3 more days until parents reported that external arm "broke off".Distractor was evaluated in the clinic and found to be broken at or around the ratchet mechanism.Surgeon believes the patient rolled on his head and snapped it.Patient was brought to the or for device removal and replacement.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the returned product.Process evaluation was also completed on the lot number provided.The stereo microscope investigation revealed tensile cracks.Further observation determined there was no indication of material of manufacturing defects.A review of the product device history files was performed based on the lot number provided.No discrepancies were found in this investigation.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.

• 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: 6373169
• Report Number: 9610905-2017-00025
• Device Sequence Number: 19122657
• Product Code: MQN
• UDI-Device Identifier: 00888118080868
• UDI-Public: (01)00888118080868
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K010139
• 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
• Report Date (Section B): 02/01/2017

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: 51-405-42-09
• Device Lot Number: 33163727
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: 5 MO