NA 04.633.330Recalls & reported problems
Synthes GmbH · TI SNAP-ON TRANSCONNECTOR 30MM-33MM FOR 5.5MM/6.0MM RODS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034746647), received between Jul 29, 2020 and Jul 29, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2020Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THERE WAS AN ISSUE INTRAOPERATIVELY WHEN DOING THE FINAL TIGHTENING OF THE CROSS-LINK SYSTEM. THE TORQUE DIDN¿T CLICK AND DAMAGED (STRIPPED) THE CROSS-LINK SCREW. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10339503 ↗
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- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
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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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