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

Model Number	24-025-07-09
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Two 20 hole plates were implanted into the patient.One of the plates was discovered broken during follow up.Surgeon decided to remove both plates on (b)(6) 2017.These plates were the replacement plates from previously reported event on mdr 9610905-2016-00044.Surgeon believes that there may be a compliance issue with the patient.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the returned sternal plate.Process evaluation was also completed on the lot number provided.Tensile cracks were observed under the stereo microscope.Further investigation determined that there was no indication of material or manufacturing defects observed.A review of the product device history files was performed on the lot number provided.No discrepancies were found in this investigation.The results of the investigation conclude that the root cause for breakages were due to mechanical overload on the device.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up will be submitted.

• Brand Name: LEVEL ONE THORACIC
• Common Device Name: PLATES
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6384747
• Report Number: 9610905-2017-00030
• Device Sequence Number: 36794
• Product Code: HRS
• UDI-Device Identifier: 00888118031761
• UDI-Public: (01)00888118031761
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2017

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: 24-025-07-09
• Device Lot Number: 33166891
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 06/12/2017
• 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: 52 YR