NA 04.633.338Recalls & reported problems
Synthes GmbH · TI SNAP-ON TRANSCONNECTOR 38MM-47MM 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034746661), received between Sep 26, 2019 and Sep 26, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT A LAMINECTOMY OF T11-L3 DUE TO A FRACTURE AT L1, ON (B)(6) 2019. PATIENT HAD A BROKEN BACK REQUIRING THE SURGERY. PATIENT IS NOW SHOWING SYMPTOMS OF HYPERSENSITIVITY TO THE METAL INSTALLED IN PATIENT¿S BACK DURING THE FUSION AND CURRENTLY EXPERIENCING INCREASED PAIN AND SKIN BREAKOUTS. AN MRI THAT WAS DONE IN (B)(6) 2019 SHOWS THAT THE PATIENT IS HEALING AS EXPECTED. THERE IS NO PLAN TO REMOVE THE IMPLANTS CURRENTLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TI SNAP-ON TRANSCONNECTOR 38 MM-47 MM FOR 5.5 MM/6.0 MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 9123447 ↗
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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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