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

Model Number 24-025-47-09

Device Problem Break (1069)

Patient Problem Impaired Healing (2378)

Event Date 09/08/2022

Event Type  Injury  

Event Description

It was reported a sternal plate broke.It was removed and replaced.

Manufacturer Narrative

An investigation was performed using a stereo microscope revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at kls se.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.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
• Type of Device: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN L.P.; p.o. box 16369; jacksonville FL 32245
• Manufacturer Contact: melissa damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 15555894
• MDR Text Key: 301326518
• Report Number: 9610905-2022-00068
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888118031860
• UDI-Public: (01)00888118031860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153482
• Exemption Number: 2017029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24-025-47-09
• Device Lot Number: 33211737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female