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

Model Number	25-879-07-91
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Mdr: 9610905-2023-000004 and mdr: 9610905-2023-000012.
Event or Problem Description
Screws used to secure a mandibular implant to a patient's mandible were found to be too short to secure the implant to the bone and were removed and replaced with longer screws.
Additional Manufacturer Narrative
Corrected data: g3: date received by manufacturer: date typo correction.B4: date of this report: date typo correction.D9 device available for evaluation: typo correction.Additional data: d9 returned to manufacturer: added information.Multiple mdr reports were filed for this event.Mdr: 9610905-2023-000004 and mdr: 9610905-2023-000012.
Additional 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.Multiple mdr reports were filed for this event.Mdr: 9610905-2023-000004 and mdr: 9610905-2023-000012.

• Brand Name: LEVEL ONE CMF
• Common Device Name: SCREW
• 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 bachorski ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 16686764
• Report Number: 9610905-2023-00012
• Device Sequence Number: 7397345
• Product Code: HRS
• UDI-Device Identifier: 00888118047793
• UDI-Public: (01)00888118047793
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K971297
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/24/2023

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: 25-879-07-91
• Device Lot Number: 33478206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/04/2023; 10/24/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 04/18/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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 Age: 75 YR
• Patient Sex: Male