Orthofix External Fixation Screw (Pin) with Hydroxyapatite coating 1 (REF 99-60613)Recalls & reported problems
Orthofix Srl · OSTEOTITE BONE SCREW 220/40 MM SHAFT D 6 MM THREAD D 6-5 MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032568862058), received between Feb 5, 2026 and Feb 5, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incomplete or Missing Packaging1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2026Incomplete or Missing Packaging
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.
Patient problems: Insufficient Information
MAUDE report 24266186 ↗
Other Pin, Fixation, Threaded devices
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall2 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- APEX 5038-1-080Stryker GmbH · PIN, FIXATION, THREADED48 reports
- Agee Digit Widget® DWD-232Hand Biomechanics Lab Inc · Pin, Fixation, Threaded32 reports
- SPATIAL FRAME 71070720Smith & Nephew, Inc. · PIN, FIXATION, THREADED15 reports
- APEX 5038-2-110Stryker GmbH · PIN, FIXATION, THREADED11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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