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

Model Number 24-015-20-71

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Impaired Healing (2378)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reference exemption number e2017029.

Event Description

Physician reported that the plate was not appropriate for patient of this size.

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 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 investigation results conclude that the root cause is patient related as no device issue was found.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
• MDR Report Key: 11591080
• MDR Text Key: 243046641
• Report Number: 9610905-2021-00022
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888118092526
• UDI-Public: (01)00888118092526
• Combination Product (y/n): N
• PMA/PMN Number: K153482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24-015-20-71
• Device Lot Number: 33258064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other