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

Model Number	51-575-17-04
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following information has been requested from the doctor - patient information, date of the event, product lot number, and implant/explant date.Once obtained a follow up report will be submitted.
Event or Problem Description
Distractor broke during treatment with the patient.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the broken distractors returned.The stereo microscope investigation revealed shear cracks.Further investigation determined that there was no indication of material or manufacturing defects observed.The device history records could not be reviewed due to the lot number not being provided by the customer.The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload.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, EXTERNAL
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6306954
• Report Number: 9610905-2017-00006
• Device Sequence Number: 1159635
• Product Code: MQN
• UDI-Device Identifier: 00888118082336
• UDI-Public: (01)00888118082336
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K972047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2017

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: 51-575-17-04
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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: 11 YR