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 Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The failure root cause cannot be determined due to the device not being 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.Multiple reports were filed for this patient, please see associated report: mdr 9610905-2019-00190 and 9610905-2020-00007.
Event or Problem Description
Patient with high bmi, low bone density and copd presented after reported vehicle crash with broken plate.Plate was removed and replaced.

• 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: 10874470
• Report Number: 9610905-2020-00120
• Device Sequence Number: 3738257
• Product Code: HRS
• UDI-Device Identifier: 00888118101440
• UDI-Public: (01)00888118101440
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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: 24-015-26-71
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/20/2020
• 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: 62 YR