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

Model Number	51-402-16-09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017 patient snapped buttress tube while yawning.The distractor was removed and replaced with plates.Patient was involved in previously reported event under mdr 9610905-2016-00059.
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.The dhr review showed no discrepancies or anomalies.The measuring of each part confirmed that all parts were correctly produced.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: 6335669
• Report Number: 9610905-2017-00015
• Device Sequence Number: 13670229
• Product Code: MQN
• UDI-Device Identifier: 00888118080776
• UDI-Public: (01)00888118080776
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2017

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: No Information
• Device Model Number: 51-402-16-09
• Device Lot Number: 33020033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• 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: 13 YR