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

Model Number	51-350-30-09
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Distractor broke at the weld between the distraction mechanism and the foot plate.Patient fell of the slide during the consolidation period.Item was removed and replaced by the same item number.
Additional Manufacturer Narrative
Tensile cracks and bending were observed under the stereo microscope.There were no indications of material or manufacturing defects observed.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 breakages were due to mechanical overload on the device.If further information can be gathered that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: ZURICH 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: 6082871
• Report Number: 9610905-2016-00039
• Device Sequence Number: 16522694
• Product Code: MQN
• UDI-Device Identifier: 00888118080493
• UDI-Public: (01)00888118080493
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/13/2016

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: 51-350-30-09
• Device Lot Number: 31682246
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 12/09/2016
• 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: 6 YR