Proficient™ Posterior Cervical Spine System 21-8320Recalls & reported problems
Spine Wave, Inc. · Screw, 3.8 mm X 14 mm · Class 2 · Implant
All models of Proficient Posterior Cervical Spine System (7)
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 10840642119107), received between Jun 18, 2024 and Aug 27, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Detachment of Device or Device Component
The was reported that the screw assembly separated during tightening. The screw was replaced with no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482431 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
A SCREW ASSEMBLY WAS BROKEN DURING USE. THE SCREW WAS REPLACED WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832873 ↗MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A SURGICAL PROCEDURE, ONE SCREW ASSEMBLY BROKE DURING INTRAOPERATIVE SCREW POSITIONING. SCREW WAS REMOVED AND REPLACED. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597148 ↗MalfunctionJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A SURGICAL PROCEDURE, ONE SCREW BROKE DURING INSERTION. THE DEVICE WAS REMOVED AND THE CASE CONTINUED WITHOUT ISSUE. NO PATIENT CONSEQUENCE AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19562760 ↗
Other Orthosis, Cervical Pedicle Screw Spinal Fixation devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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