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

Model Number	51-426-30-09
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the distractors broke therefore event date could not be determined.(b)(4).Reference exemption number e2017029.
Event or Problem Description
Patient underwent a mandibular distraction.Two of the distractors broke at the proximal plate on both sides of the rod.Right side maintained distraction length, but the left side did not.The break is believed to have occurred during the consolidation phase.A scan was taken in february and everything was ok.When patient underwent another scan on (b)(6) 2017 it appeared the distractors broke off.Patient went back to the operating room (or) on (b)(6) 2017 and both distractors were removed.The patient had finished the consolidation phase.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the broken distractors returned.Process evaluation was also performed based off the lot number provided.Tensile cracks were observed under the stereo microscope.It was determined there were no indications of material or manufacturing defects.The product device history records were also reviewed based on the lot numbers provided, and no anomalies were found.The investigation results conclude that the root cause for breakages was due to structural failure of the device due to mechanical overload.

• 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: 6593890
• Report Number: 9610905-2017-00044
• Device Sequence Number: 808785
• Product Code: MQN
• UDI-Device Identifier: 00888118081360
• UDI-Public: (01)00888118081360
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K010139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/26/2017
• Report Date (Section F): 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 51-426-30-09
• Device Lot Number: 33173358, 32244720
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2017
• Date Report to Manufacturer: 04/26/2017
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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: 9 YR