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

Model Number 50-396-06-91

Device Problem Break (1069)

Patient Problem Impaired Healing (2378)

Event Date 09/09/2022

Event Type  Injury  

Event Description

It was reported a plate broke, possibly due to patient coughing.It was removed and replaced.

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 kls se.During the investigation the product lot number was not identified; therefore, the device history records were not reviewed.Based on the information provided the results conclude that the most likely root cause is patient related.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Correction: d9 - product not available for return.G1 - contact person and contact email.

• Brand Name: LEVEL ONE CMF
• 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: 15509474
• MDR Text Key: 300887006
• Report Number: 9610905-2022-00069
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118075970
• UDI-Public: (01)00888118075970
• Combination Product (y/n): N
• Reporter Country Code: TD
• PMA/PMN Number: K943347
• 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: 01/26/2024

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
• Device Operator: Health Professional
• Device Model Number: 50-396-06-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: Male