MAUDE Adverse Event Report: ORTHOFIX SRL OSTEOTITE BONE SCREW 220/40 MM SHAFT D 6 MM THREAD D 6-5 MM

Catalog Number	99-60613
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Received information stating that a truelok plus kit was delivered incomplete.As per reporter, the surgical procedure was completed using a conventional external fixator, but the patient will undergo a revision procedure to add a ring fixator.
Additional Manufacturer Narrative
No product was returned as product available was implanted, no allegation of product malfunction was reported by user.Orthofix has requested further information on the event.Should further information become available, orthofix will provide you with a follow-up report.
Event or Problem Description
Received information stating that a truelok plus kit was delivered incomplete.As per reporter, the surgical procedure was completed using a conventional external fixator, but the patient will undergo a revision procedure to add a ring fixator.
Additional Manufacturer Narrative
No product was returned as product available was implanted.No allegation of product malfunction was reported by user.

• Brand Name: OSTEOTITE BONE SCREW 220/40 MM SHAFT D 6 MM THREAD D 6-5 MM
• Common Device Name: OSTEOTITE BONE SCREW 220/40 MM SHAFT D 6 MM THREAD D 6-5 MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 24266186
• Report Number: 9680825-2026-00008
• Device Sequence Number: 10658403
• Product Code: JDW
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K974186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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 Catalogue Number: 99-60613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male