Proficient Posterior Cervical Spine SystemRecalls & reported problems across all models
Spine Wave, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 7 models of Proficient Posterior Cervical Spine System by Spine Wave, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2017 and Aug 27, 2026 — classified as 7 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Proficient Posterior Cervical Spine System problems
Device problems
- Detachment of Device or Device Component12
- Loose or Intermittent Connection3
- Detachment Of Device Component2
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
- Disconnection1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient4
- No Code Available2
- Failure of Implant1
- Insufficient Information1
Proficient Posterior Cervical Spine System models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Proficient™ Posterior Cervical Spine System 11-8999Orthosis, Cervical Pedicle Screw Spinal Fixation11 reports
- Proficient™ Posterior Cervical Spine System 21-8320Orthosis, Cervical Pedicle Screw Spinal Fixation4 reports
- Proficient™ Posterior Cervical Spine System 11-8029Orthosis, Cervical Pedicle Screw Spinal Fixation1 report
- Proficient™ Posterior Cervical Spine System 11-8059Orthosis, Cervical Pedicle Screw Spinal Fixation1 report
- Proficient™ Posterior Cervical Spine System 11-8061Orthosis, Cervical Pedicle Screw Spinal Fixation1 report
- Proficient™ Posterior Cervical Spine System 11-8082Orthosis, Cervical Pedicle Screw Spinal Fixation1 report
- Proficient™ Posterior Cervical Spine System 21-8319Orthosis, Cervical Pedicle Screw Spinal Fixation1 report
Recent Proficient Posterior Cervical Spine System adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
A SCREW ASSEMBLY BROKE. THE SCREW WAS REPLACED WITH NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832688 ↗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 ↗MalfunctionAug 20, 2024Detachment 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 20002013 ↗MalfunctionAug 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A SURGICAL PROCEDURE, ONE SCREW BROKE DURING INSERTION. NO PATIENT CONSEQUENCE WAS REPORTED. SCREW WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19992554 ↗InjuryJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
APPROXIMATELY ONE MONTH POST-OPERATIVELY, A PROCEDURE WAS PERFORMED TO REMOVE A SINGLE LOOSE LOCKING SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19755856 ↗MalfunctionJul 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A SURGICAL PROCEDURE, ONE SCREW BROKE DURING INSERTION. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711511 ↗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 ↗MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AT AN UNSPECIFIED TIME POST-OPERATIVELY, DURING AN UNRELATED SURGICAL PROCEDURE TWO LOOSE LOCKING SCREWS WERE IDENTIFIED AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19164330 ↗MalfunctionAug 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AT APPROXIMATELY 8 WEEKS POST-OPERATIVELY, A LOOSE LOCKING SCREW AND SPINAL ROD IN A PEDICLE SCREW CONSTRUCT WERE IDENTIFIED. NO INTERVENTION HAS BEEN TAKEN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17500369 ↗MalfunctionAug 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AT AN UNSPECIFIED TIME POST-OPERATIVELY, A LOOSE LOCKING SCREW IN A PEDICLE SCREW CONSTRUCT WAS IDENTIFIED. NO INTERVENTION HAS BEEN TAKEN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17500300 ↗InjuryJun 3, 2022Disconnection
AFTER APPROXIMATELY 5 MONTHS POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE LOCKING SCREWS THAT HAD DISSOCIATED FROM THE SCREW HEADS IN A MULTI-LEVEL CERVICO-THORACIC CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 14594654 ↗InjuryMar 2, 2021Material Separation
AT APPROXIMATELY THREE YEARS POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE LOCKING SCREWS THAT HAD DISSOCIATED FROM THE SCREW HEAD IN A MULTI-LEVEL CERVICO-THORACIC CONSTRUCT.
Patient problems: Insufficient Information
MAUDE report 11401574 ↗InjuryFeb 19, 2020Loose or Intermittent Connection
APPROXIMATELY 4 WEEKS POST-OPERATIVELY, THE SURGEON NOTED ON RADIOGRAPHIC IMAGING THAT THE LOCKING SCREWS DID NOT APPEAR TIGHT. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE LOCKING SCREWS AND EXTEND THE CONSTRUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9729765 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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