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

Model Number	24-025-49-09
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of two related mdrs.Please refer to mdr 9610905-2016-00054.
Event or Problem Description
Patient heard from the er that the plates may have broken and complained of pain thereafter.The surgeon decided to explant the plates.The sternum healed and the plates were hardly displaced.Surgeon was happy with the results.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics and data analysis as no device was sent back for evaluation.It is determined that the complaint percentage falls well within the product risk limits that are adhered to at klm.The product history device records could not be reviewed since no lot was provided by the reporter.Due to no device being returned the root cause for the failure cannot be determined.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: 6178065
• Report Number: 9610905-2016-00053
• Device Sequence Number: 497146
• Product Code: HRS
• UDI-Device Identifier: 00888118031884
• UDI-Public: (01)00888118031884
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2016

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: 24-025-49-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR