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

Model Number	51-423-30-09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was having previously broken distractors (reported on mdr 9610905-2016-00048) replaced.After devices were implanted the surgeon tested the distractors and both broke.The distractors were removed and replaced during the same case.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the distractors that were returned.Process evaluation was also performed based off the lot number provided.Tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacture defects.The product history device records were reviewed based on the lot number provided and no abnormalities were found.The results of the investigation conclude that the root cause for the breakage was 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: 6177544
• Report Number: 9610905-2016-00049
• Device Sequence Number: 929176
• Product Code: MQN
• UDI-Device Identifier: 00888118081216
• UDI-Public: (01)00888118081216
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/18/2016

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: 51-423-30-09
• Device Lot Number: 32826688
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 03/03/2017
• 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: 1 YR