Solanas 75000-056Recalls & reported problems
Alphatec Spine, Inc. · OCCIPITAL PLATE ASSEMBLY, 56mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844856068728), received between Sep 27, 2016 and Feb 12, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fitting Problem” (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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Fitting Problem1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2019Fitting Problem
AFTER SETTING THE ROD ON BUSHING OF OCCIPITAL BONE PLATE, THE DOCTOR INSTALLED AVALON SET SCREWS. BOTH OF THE BUSHINGS WERE WIDENED BY THE INSTALLATION AND SET SCREWS COULD NOT BE TIGHTENED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8331516 ↗InjurySep 27, 2016Appropriate Device Problem Term/Code Not Available
AFTER PLACING THE ROD INTO THE LEFT SIDE OF THE 56MM AVALON PLATE, SET SCREWS WERE INSTALLED AND TIGHTENED, SPLAYING THE "TULIP" REPEATEDLY. THE PLATE WAS REMOVED AND ANOTHER 56MM PLATE AND RESCUE SCREWS INSTALLED. THIS TIME, THE ROD ON THE LEFT SIDE WENT IN FINE BUT THE ROD ON THE RIGHT HAD THE SAME SPLAY ISSUE. IN BOTH OCCURRENCES IT APPEARED TO BE THE RIGHT HALF OF THE TULIP WHICH SPLAYED. THE EXCHANGE OF OCCIPITAL PLATES CAUSED OVER A 30 MINUTE DELAY IN THE CASE.
Patient problems: No Code Available
MAUDE report 5980183 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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