AVS Anchor-L Lumbar Cage System 48994000Recalls & reported problems
Stryker Corporation · MODULAR FLEXIBLE SCREWDRIVER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327274578), received between Apr 6, 2016 and Nov 7, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Most reported problems
Device problems
- Break4
- Fracture4
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT WHILE INSERTING A SCREW WITH THE FLEXIBLE SCREW DRIVER. THE SCREW DRIVER BROKE. SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8048304 ↗MalfunctionOct 22, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT THE TIP OF THE FLEXIBLE SCREWDRIVER BROKE. THERE WAS NO SURGICAL DELAY, ALL BROKEN FRAGMENTS WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7993741 ↗MalfunctionSep 5, 2017Fracture; Break; Fracture
IT WAS REPORTED THAT; SCREWDRIVER TIP BROKE.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 6843619 ↗MalfunctionApr 6, 2016Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT WAS REPORTED THAT THE SURGEON WAS INSERTING A SCREW WHEN THE SCREWDRIVER TIP BROKE. ANOTHER SCREWDRIVER WAS USED IN ITS PLACE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5551885 ↗
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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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