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

Model Number	24-025-51-09
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
A sternal plate broke after implantation.The patient did not undergo a secondary surgery.The plate remains in patient's body.
Additional Manufacturer Narrative
Methods: complaint statistics and process evaluation based on the lot number results: an investigation was performed on the basis of complaint statistics since no device was returned 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 were also reviewed based on the lot number provided, and no abnormalities were found.Assessment conclusion: due to no device being returned and the device history records showed no abnormality, 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.
Additional Manufacturer Narrative
It was originally reported that only one sternal plate had broken in the patient.During the explant surgery on (b)(6) 2017 it was discovered that two sternal plates and a rib plate broke in the patient.The sternal plates have identical model and lot numbers.The rib plate has been filled under a separate mdr (9610905-2017-00045).

• Brand Name: LEVEL ONE THORACIC PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 5849764
• Report Number: 9610905-2016-00029
• Device Sequence Number: 16209945
• Product Code: HRS
• UDI-Device Identifier: 00888118031907
• UDI-Public: (01)00888118031907
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 07/29/2016

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: 24-025-51-09
• Device Lot Number: 33124882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/25/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/05/2016
• Supplement Report FDA Received Date: 08/19/2016; 04/18/2017
• 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