MAUDE Adverse Event Report: KLS MARTIN SE & CO. KG LEVEL ONE CMF; SCREW

Model Number	25-879-05-91
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A screw in a palatal expander footplate was found to be loose two months after implant and after successful consolidation had been achieved.It was removed along with the palatal expander.
Additional Manufacturer Narrative
An investigation was performed in the lab and 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.Review of the device history records was not possible due to no lot number being identified.The investigation results conclude that the root cause for this failure could not be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Corrections: d3 - manufacturer - establishment name only updated.G1 - all manufacturers - establishment name only updated.G1 - all manufacturers - manufacturing site for devices - establishment name and address - corrected.

• Brand Name: LEVEL ONE CMF
• Common Device Name: SCREW
• Manufacturer (Section D): KLS MARTIN SE & CO. KG; kolbinger strasse 10; muehlheim/donau,
• Manufacturer (Section G): KLS MARTIN L.P.; p.o. box 16369; jacksonville FL 32245
• Manufacturer Contact: melissa bachorski ; kolbinger strasse 10; muehlheim/donau, de, FL 78570 ; GM 78570 ; 9046417746
• MDR Report Key: 17438236
• Report Number: 9610905-2023-00036
• Device Sequence Number: 6834826
• Product Code: HRS
• UDI-Device Identifier: 00888118047755
• UDI-Public: (01)00888118047755
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Device Explanted 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
• Report Date (Section B): 05/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: 25-879-05-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 06/05/2024
• 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: Female