SAPPHIRE 27240-014Recalls & reported problems
Spinal Elements, Inc. · SAPPHIRE® Ø4.0MM x 14MM SELF-DRILLING VARIABLE-ANGLE SCREW · Class 2 · Implant
Data updated Oct 13, 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 00840606108546), received between Jan 16, 2020 and Dec 21, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Failure to Osseointegrate1
- Loss of Osseointegration1
Patient problems
- Failure of Implant2
- Neck Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2021Failure to Osseointegrate; Detachment of Device or Device Component; Failure to Osseointegrate; Detachment of Device or Device Component
ON (B)(6) 2021, PATIENT UNDERWENT ANTERIOR CERVICAL FUSION (ACDF) SURGERY WITH A TWO LEVEL ANTERIOR CERVICAL PLATE (ACP) C5-C7 AND WAS FINE AT THREE WEEK FOLLOW UP. REPORTEDLY ON (B)(6) 2021, RADIOGRAPHS DEPICTED THE LEFT C7 BONE SCREW ON THE ACP HAD BACKED OUT. PATIENT THROAT IRRITATION AND NECK PAIN. ON (B)(6) 2021 REVISION SURGERY WAS PERFORMED TO REPLACE THE C7 SCREW.
Patient problems: Failure of Implant; Neck Pain
MAUDE report 13054433 ↗MalfunctionJan 16, 2020Loss of Osseointegration; Detachment of Device or Device Component; Loss of Osseointegration; Detachment of Device or Device Component
ON (B)(6) 2019, PATIENT UNDERWENT A ONE LEVEL ACDF AT C5-C6. REPORTEDLY DURING ROUTINE FOLLOW UP ON (B)(6) 2019, RADIOGRAPHS DEPICTED THE LEFT C5 BONE SCREW HAD BACKED OUT. ON (B)(6) 2019, REVISION SURGERY WAS PERFORMED AND ANTERIOR HARDWARE WAS REMOVED AND ANOTHER PLATE WAS IMPLANTED. PATIENT WAS ASYMPTOMATIC AT THE TIME OF THE EVENT AND POST- REVISION.
Patient problems: Failure of Implant
MAUDE report 9599327 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Elegance® Anterior Cervical Plate 53430353Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430108Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430236Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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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