MAUDE Adverse Event Report: I.T.S. GMBH CORTICAL SCREW, D=3.5MM; CORTICAL SCREW, D=3.5MM, L=14MM

Model Number	32351-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have inspected the dhf of the affected plate and multiple lots of screws supplied to the distributor as no lot no.Was provided and the material certificate and the batch was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The article met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Based on the information available, no final conclusion could be drawn and it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If information is obtained that was not available for the initial medwatch, a follow up medwatch will be filed as appropriate.This report does not reflect a conclusion by fda, i.T.S.Gmbh or its employees that the report constitutes an admission that the device caused or contributed to the potential event described in this report.This report includes one plate and 9 screws and therefore this is report 2/10.
Event or Problem Description
It was reported that 1 month post-op the patient had sort of allergic reaction/immune response.Seven months post-op the plate and screws were explanted and images show that non-locking screws of a different manufacturer were used in conjunction with i.T.S.Implants.

• Brand Name: CORTICAL SCREW, D=3.5MM
• Common Device Name: CORTICAL SCREW, D=3.5MM, L=14MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• MDR Report Key: 20629305
• Report Number: 3004369035-2024-00702
• Device Sequence Number: 7392949
• Product Code: HWC
• UDI-Device Identifier: 09120034302183
• UDI-Public: 09120034302183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 32351-14
• Device Catalogue Number: 32351-14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic