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

Model Number	24-025-44-09
Health Effect - Clinical Code	Chills (2191)
Type of Reportable Event	Serious Injury
Event or Problem Description
Three (3) plates were fixated.Several months after the surgery, screw and plate pulled out of bone on left sternal halve.Screws were locked into plate.Per surgeon, pt "came in with a cough, and left with a cough." patient also had a bmi of (b)(6).Plates not removed at this time.
Additional Manufacturer Narrative
Methods: complaint statistics.Results: an investigation was performed on the basis of complaint statistics 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.In addition to no device being returned, device history records could not be reviewed because no lot number or traceable identification to conduct a proper investigation was provided.Assessment conclusion : due to no device being returned and no lot number provided, the root cause for the failure cannot be determined.If further information can be gathered that might add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE THORACIC
• Common Device Name: STERNAL PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 5957127
• Report Number: 9610905-2016-00033
• Device Sequence Number: 13595629
• Product Code: HRS
• UDI-Device Identifier: 00888118031846
• UDI-Public: (01)00888118031846
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2016

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: Health Professional
• Device Model Number: 24-025-44-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2016
• Supplement Report FDA Received Date: 10/12/2016
• 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