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

Model Number	24-015-27-71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported plates broke and were removed.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The failure root cause cannot be determined due to no device being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Possible lot numbers with manufacturing dates identified during investigation: 33214630 2017-aug-21, 33226054 2017-nov-30.
Additional Manufacturer Narrative
A manufacturer's evaluation was performed using high powered stereo microscopy which revealed tensile cracks consistent with mechanical overload of the device.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it was determined that the complaint percentage falls within the design risk limits adhered to by the manufacturer.During the investigation the product lot number was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The investigation results conclude that the root cause for the breakages was structural failure due to mechanical overload of the device, most likely patient-related.If further information is obtained that might add value to the contents of the manufacturer's evaluation report, an additional follow-up report will be submitted.Corrected/additional data: product return date: 02/13/2019.Lot numbers identified during investigation of explanted devices: 33214630 mfg.Date: 21aug2017.33226054 mfg.Date: 30nov2017.Company contact: (b)(4).

• Brand Name: LEVEL ONE THORACIC
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: melissa bachorski ; po box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 8344772
• Report Number: 9610905-2019-00040
• Device Sequence Number: 19311756
• Product Code: HRS
• UDI-Device Identifier: 00888118101419
• UDI-Public: (01)00888118101419
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023
• Report Date (Section F): 01/30/2019

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: 24-015-27-71
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 08/02/2023
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 06/18/2019; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown