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

Model Number	51-563-30-09
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/03/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow up appointment patient's family said they had difficulty turning affected side.Doctor was able to turn the device however was unable to feel/hear any feedback that the device was advancing.Doctor upped to 1 1/2 turns.On (b)(6) 2016 the patient showed up to follow up appointment and the distractor was broken.Secondary surgery was performed to remove and replace broken device.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the broken plate that was 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: 6227080
• Report Number: 9610905-2016-00058
• Device Sequence Number: 16382494
• Product Code: MQN
• UDI-Device Identifier: 00888118082145
• UDI-Public: (01)00888118082145
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2016

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: 51-563-30-09
• Device Lot Number: 33169560
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 04/13/2017
• 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: 4 YR