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

Model Number	51-567-09-09
Medical Device Problem Codes	Use of Device Problem (1670); Separation Problem (4043)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported that the product came apart.Product was removed from patient, larger product was implanted in its place.
Additional Manufacturer Narrative
An investigation was performed using a stereo microscope which only revealed surface damage.Device function was tested and there was no failure detected.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was not calculated and the device history records and risk files were not reviewed, as no product failure was found.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
• Common Device Name: DISTRACTION
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8143591
• Report Number: 9610905-2018-00336
• Device Sequence Number: 13889647
• Product Code: MQN
• UDI-Device Identifier: 00888118101952
• UDI-Public: (01)00888118101952
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018
• Report Date (Section F): 11/29/2018

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: 51-567-09-09
• Device Lot Number: 33271317
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/25/2019
• 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: 36 YR