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

Model Number	24-015-27-71
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
Plate fractured after it was implanted in the patient.The patient can feel the plate move when moving and is in pain.The plate is being left in the patient for now.If pain does not decrease over time, the plate will be removed.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the plate that was returned.Process evaluation was also completed on the lot number provided.The stereo microscope investigation revealed tensile cracks.Further investigation determined that there was no indication of material or manufacturing defects observed.The review of the product device history records was performed on the lot number provided.In this investigation no anomalies were discovered.The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload.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 strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6606125
• Report Number: 9610905-2017-00048
• Device Sequence Number: 628293
• Product Code: HRS
• UDI-Device Identifier: 00888118101419
• UDI-Public: (01)00888118101419
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2017
• Report Date (Section F): 05/02/2017

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: 24-015-27-71
• Device Lot Number: 33179526
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2017
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: 27 YR