DUALXS T/PLIF 8 DEG x 7-9MM 12941001003Recalls & reported problems
Amplify Surgical, Inc. · Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm): 9 · 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 B707129410010030), received between Jan 29, 2026 and Jan 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Spinal deformity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2026Loosening of Implant Not Related to Bone-Ingrowth; Migration
DR. DID NOT USE EXPANDABLE TRIAL. DR. IMPLANTED A DUALX SLIM INTO PATIENT. DURING EXPANSION SURGICAL SITE GAVE AUDIBLE POP SOUND DURING EXPANSION (CANNOT CONFIRM IMPLANT OR ANATOMY). UNDER LATERAL XRAY IMPLANT SHOWS EXPANDED AND IN CORRECT POSITION BUT POSTERIOR PORTION APPEARS TO NOT BE CLEAR OF POSTERIOR FORAMEN. LOCK SCREW WOULD NOT THREAD INTO NOSE. INSTRUMENTS WERE DISCONNECTED FROM IMPLANT IN AN ATTEMPT TO GET LOCK SCREW TO THREAD INTO NOSE. LOCK SCREW WOULD NOT THREAD INTO NOSE. LOCK SCREW WAS REMOVED. IMPLANT WAS MALLETED FORWARD TO CLEAR POSTERIOR NEURAL ELEMENTS. LATERAL XRAY SHOWS EXPANDED IMPLANT BUT ANTERIOR OF THE VERTEBRAL BODY. AP XRAY SHOWS POSTERIOR PORTION OF IMPLANT ONLY PARTIALLY EXPANDED (IMPLANT APPEARS TO BE INTACT AND COMPONENTS NOT BROKEN OR DISLOCATED). ATTEMPTS TO RE-ATTACH INSTRUMENTS TO IMPLANT FAILED. IMPLANT LEFT IN PATIENT PARTIALLY LATERALLY EXPANDED AND PARTIALLY VERTICALLY EXPANDED WITHOUT LOCK SCREW.
Patient problems: Spinal deformity
MAUDE report 24218202 ↗
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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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