Cannulated Screw System + 04.355.895Recalls & reported problems
Tyber Medical, LLC · 7.5MM TI CANN SCREW + FT - 95MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810040681219), received between Jun 21, 2023 and May 13, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break
IT WAS REPORTED ON (B)(6) 2026 AS SURGEON WAS IMPLANTING SCREW THE HEAD SNAPPED OFF. SURGEON WAS ABLE TO RETRIEVE BROKEN SCREW WITH MINIMAL DAMAGE TO SURROUNDING BONE. THIS EXTENDED SURGERY APPROXIMATELY 30 MINUTES TO REMOVE AND IMPLANT NEW SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160835 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, A 7.5 CSS+ SCREW BROKE WHEN INSERTING IT INTO THE BONE. VERY LITTLE RESISTANCE NEEDED TO BREAK THE HEAD OFF. SURGERY WAS DELAYED FOR 30 MINUTES. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24959133 ↗MalfunctionDec 15, 2023Fracture; Fracture
IT WAS REPORTED THAT ON AN UNKNOWN DATE REAMER SHAFTS WERE BENT AT THE TIP AFTER REAMING. REAMER HEADS WOULD NOT SNAP ON. STAPLE WAS USED AND RELEASED EARLY WHENEVER WE TRIED TO MALLET STAPLE GENTLY WHILE DRILLING LINE TO LINE, 7.5 X 95 X 2 SCREWS HAD NO PURCHASE AND THE TIP SEEMED TO BREAK OFF WHILE INSERTION. WE DID NOT PREDRILL. STAPLE, AND SCREWS WERE NOT CHARGED TO PATIENT AND STILL IMPLANTED. THERE WERE 3 MINS OF SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18336802 ↗InjuryJun 21, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023 DURING PELVIC SURGERY INTRAOPERATIVELY THE HEAD OF A 7.5MMX95MM FULLY THREADED CSS+ SCREW BROKE OFF IN THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 45 MINUTES. THIS COMPLAINT INVOLVES ONE(1) DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17171875 ↗
Other Screw, fixation, bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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