4WEB Medical PSTS-SM0610-22-SPRecalls & reported problems
4web Medical · 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 00812998022304), received between Sep 24, 2019 and Sep 24, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2019Migration; Migration
IT WAS REPORTED THAT THE PATIENT REQUIRED AN INITIAL REVISION SURGERY TWO DAYS AFTER THE ORIGINAL SURGERY, WHERE THE IMPLANT WAS REPOSITIONED SINCE IT WAS OBSERVED THAT IT HAD MIGRATED. ABOUT 45 DAYS FOLLOWING THE FIRST REVISION SURGERY, IT WAS OBSERVED BY THE SURGEON THAT THE IMPLANT HAD MIGRATED POSTERIORLY AGAIN. A SECOND REVISION SURGERY WAS PERFORMED WHERE THE IMPLANT WAS REMOVED FROM THE PATIENT AND REPLACED WITH BONE GRAFT. NO COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9112385 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
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- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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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