Zodiac 62979Recalls & reported problems
Alphatec Spine, Inc. · ADJUSTABLE BRIDGE DRIVER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844856026810), received between Jun 28, 2016 and Nov 29, 2018 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break7
- Detachment Of Device Component3
- Component Missing1
- Fracture1
- Loose or Intermittent Connection1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2018Break; Fracture; Loose or Intermittent Connection
SURGEON WAS INSTALLING CROSSLINK AND PART OF IT DIDN'T COMPLETELY LOCK. SURGEON UNLOCKED AND LOCKED ONCE AGAIN BUT PART OF IT WAS IN A WEIRD POSITION. DURING THIS TIME THE DISTAL TIP OF THE BRIDGE DRIVER FRACTURE AND BROKE. THE EVENT CAUSED NO PATIENT HARM. THE CASE WAS SUCCESSFUL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8116835 ↗MalfunctionNov 30, 2016Break
InjuryNov 10, 2016Break; Detachment Of Device Component
THE TIP BROKE OFF IN THE PATIENT DURING SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 6094548 ↗MalfunctionOct 12, 2016Break; Component Missing
THE DISTAL TIP MISSING/BROKEN FROM THE ZODIAC DRIVER. NO PATIENT INVOLVED. IT WAS DISCOVERED AS REP WAS SETTING UP FOR THE CASE.
Patient problems: No Information
MAUDE report 6020681 ↗MalfunctionOct 4, 2016Break; Detachment Of Device Component
THE TIP OF THE ZODIAC DRIVER BROKE OFF DURING USE. THE EVENT CAUSED NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5998017 ↗InjuryAug 17, 2016Break; Detachment Of Device Component
THE TIP OF THE ZODIAC DRIVER BROKE OFF DURING FINAL TIGHTENING. THE DETACHED SECTION REMAINS POSITIONED WITHIN THE SET SCREW OF THE IMPLANTED ADJUSTABLE BRIDGE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5883596 ↗MalfunctionJun 28, 2016Break
TIP OF THE ZODIAC BRIDGE DRIVER WAS FOUND MISSING/BROKEN DURING ROUTINE INSPECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5755055 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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