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

Model Number	24-023-11-91
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dementia (1808); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Multiple mdr reports were filed for this event, please see associated report: mdr 9610905-2018-00096.
Event or Problem Description
It was reported the patient developed an infection and the implant was removed.
Additional Manufacturer Narrative
An investigation was performed using a stereo microscope revealed surface damage.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.The product lot number could not be identified; therefore, the device history records were not reviewed.The investigation results conclude that the root cause is patient related as no device issue 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.Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00096.

• Brand Name: LEVEL ONE THORACIC
• Common Device Name: RECON TALON
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau 78570 ; GM 78570
• MDR Report Key: 7630365
• Report Number: 9610905-2018-00097
• Device Sequence Number: 2435619
• Product Code: HRS
• UDI-Device Identifier: 00888118031624
• UDI-Public: (01)00888118031624
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018
• Report Date (Section F): 06/01/2018

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: Physician
• Device Model Number: 24-023-11-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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: 66 YR