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

Model Number	51-405-42-09
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	11/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of two related mdrs.Please refer to mdr 9610905-2017-00092.Received medwatch report no.Mw5073344 regarding this event.An investigation was performed based on complaint statistics as no device was returned for evaluation.The complaint percentage falls within the design risk limits adhered to at (b)(4).Process analysis on the lot number provided and product testing on current production was also performed.The device history review determined there were no abnormalities.Samples of current production were tested and compared to test reports from the dhr.No abnormalities were discovered during this review.The instructions for use was reviewed and determined the relevant warnings are included.Due to no abnormalities discovered during the investigation and no product was returned the root cause for the failure cannot be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up will be submitted.(b)(4).Reference exemption number e2017029.
Event or Problem Description
On (b)(6) 2017 part of the right distractor was found broken within the patient's head bandage.Patient underwent an additional surgery where both distractors were removed and a different surgical procedure was completed that did not involve distractors.

• 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: 7110444
• Report Number: 9610905-2017-00093
• Device Sequence Number: 11130827
• Product Code: MQN
• UDI-Device Identifier: 00888118080868
• UDI-Public: (01)00888118080868
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2017
• Report Date (Section F): 11/12/2017

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: 51-405-42-09
• Device Lot Number: 33195426
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2017
• Initial Report FDA Received Date: 12/12/2017
• 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: 2 YR