MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE THORACIC; PLATE

Model Number	24-015-26-71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported that plates broke.Currently there are no plans to remove them.
Additional Manufacturer Narrative
New information received - explant date.Multiple mdr reports were filed for this event, associated report: mdr: 9610905-2019-00049.
Additional Manufacturer Narrative
Initial reporter (facility) mdr#: (b)(4).
Additional Manufacturer Narrative
Device material number nor lot number was identified therefore complaint rate, review of device history records and risk file was not possible.The root cause for the failure cannot be determined since neither material number nor lot number were provided, and the device was not returned.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: LEVEL ONE THORACIC
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8344785
• Report Number: 9610905-2019-00043
• Device Sequence Number: 2105708
• Product Code: HRS
• UDI-Device Identifier: 00888118101440
• UDI-Public: (01)00888118101440
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/07/2019
• Report Date (Section F): 02/07/2019

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: Health Professional
• Device Model Number: 24-015-26-71
• Device Lot Number: 33217945
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 08/07/2019; 09/16/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 06/03/2019; 08/15/2019; 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1