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

Model Number	50-348-05-09
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Correcting the mfr report number due to a typo.This was originally submitted as 9610905-2018-02018 on 05/29/2018.This was originally corrected with 9610905-2018-00073-1 on 05/30/2018.
Event or Problem Description
It was reported that screws became loose.The screws were removed.

• Brand Name: DISTRACTION
• Common Device Name: DISTRACTION
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, fl ; 6417746
• MDR Report Key: 7552578
• Report Number: 9610905-2018-00073
• Device Sequence Number: 2502649
• Product Code: MQN
• UDI-Device Identifier: 00888118075635
• UDI-Public: (01)00888118075635
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K010139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018
• Report Date (Section F): 05/07/2018

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: Health Professional
• Device Model Number: 50-348-05-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 05/30/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4), DISTRACTION, INTERNAL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR
• Patient Sex: Female