Streamline TL Spinal Fixation System 02-FINALDRIVERRecalls & reported problems
Xtant Medical Holdings, Inc. · Final Driver · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840311251230), received between Jun 10, 2026 and Jul 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816938 ↗MalfunctionJul 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816595 ↗MalfunctionJun 10, 2026Break
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 05/12/2026. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS BROKEN DURING A PROCEDURE PERFORMED ON (B)(6) 2026, AND WAS REQUESTED TO BE REPLACED. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 06/03/2025. NO FURTHER INFORMATION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462488 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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