OASYS 48551000Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 04546540371508), received between Apr 25, 2016 and Jan 16, 2024 — classified as 23 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Migration” (33 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 2 WEEKS AFTER IMPLANTATION TO ADDRESS THE MIGRATION OF FOUR OASYS BLOCKERS. FROM THE IMAGING PROVIDED, IT WAS ALSO OBSERVED THAT A TULIP OF ONE UNKNOWN OASYS SCREW HAS DISENGAGED. THIS REPORT CAPTURES THE SECOND OF FOUR BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519835 ↗
• InjuryJan 16, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 2 WEEKS AFTER IMPLANTATION TO ADDRESS THE MIGRATION OF FOUR OASYS BLOCKERS. FROM THE IMAGING PROVIDED, IT WAS ALSO OBSERVED THAT A TULIP OF ONE UNKNOWN OASYS SCREW HAS DISENGAGED. THIS REPORT CAPTURES THE THIRD OF FOUR BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518565 ↗
• InjuryJan 16, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 2 WEEKS AFTER IMPLANTATION TO ADDRESS THE MIGRATION OF FOUR OASYS BLOCKERS. FROM THE IMAGING PROVIDED, IT WAS ALSO OBSERVED THAT A TULIP OF ONE UNKNOWN OASYS SCREW HAS DISENGAGED. THIS REPORT CAPTURES THE FOURTH OF FOUR BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518561 ↗
• InjuryJan 16, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 2 WEEKS AFTER IMPLANTATION TO ADDRESS THE MIGRATION OF FOUR OASYS BLOCKERS. FROM THE IMAGING PROVIDED, IT WAS ALSO OBSERVED THAT A TULIP OF ONE UNKNOWN OASYS SCREW HAS DISENGAGED. THIS REPORT CAPTURES THE FIRST OF FOUR BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518556 ↗
• InjuryJun 23, 2023Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY ONE-MONTH POST-OPERATIVELY ONE OASYS BLOCKER ON THE RIGHT SIDE OF C2 MIGRATED. REVISION SURGERY HAS BEEN PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195061 ↗
• MalfunctionOct 1, 2021Migration; Migration

  THIS RECORD CAPTURES A REVIEW OF LITERATURE ARTICLE "MECHANICAL IMPLANT FAILURE IN POSTERIOR CERVICAL SPINE FUSION" FROM THE EUROPEAN SPINE JOURNAL. THE AIM OF THIS STUDY WAS TO DETERMINE WHETHER THE RECENT REFINEMENT AND DOWNSIZING OF THE IMPLANTS FOR POSTERIOR CERVICAL FUSION INCREASE THE OCCURRENCE OF IMPLANT FAILURE. ONE HUNDRED FORTY-TWO CONSECUTIVE CASES OF CERVICAL FUSION DURING A 12-YEAR PERIOD FROM JANUARY 1998 TO DECEMBER 2009, USING EITHER CANNULATED MAGERL SCREWS OR A MULTIAXIAL PEDICLE SCREW¿ROD SYSTEM, WERE REVIEWED RETROSPECTIVELY AFTER AN AVERAGE FOLLOW-UP PERIOD OF MORE THAN 3 YEARS, AND THE RATE AND CHARACTERISTICS OF THE FAILURE OF THESE IMPLANTS WERE EVALUATED. FORTY ONE PATIENTS WERE IMPLANTED WITH OASYS IMPLANTS. IT WAS REPORTED THAT PATIENT 5 EXPERIENCED AN OASYS "SCREW DISASSEMBLY" AT C7 1 MONTH POST-OPERATIVELY. SPECIFICALLY, THE OASYS BLOCKER MIGRATED FROM IT'S RESPECTIVE SCREW AS EVIDENT FROM X-RAY IMAGING. REVISION SURGERY WAS NOT PERFORMED AS THE PATIENT REMAINED ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562713 ↗
• MalfunctionOct 1, 2021Migration; Migration

  THIS RECORD CAPTURES A REVIEW OF LITERATURE ARTICLE "MECHANICAL IMPLANT FAILURE IN POSTERIOR CERVICAL SPINE FUSION" FROM THE EUROPEAN SPINE JOURNAL. THE AIM OF THIS STUDY WAS TO DETERMINE WHETHER THE RECENT REFINEMENT AND DOWNSIZING OF THE IMPLANTS FOR POSTERIOR CERVICAL FUSION INCREASE THE OCCURRENCE OF IMPLANT FAILURE. ONE HUNDRED FORTY-TWO CONSECUTIVE CASES OF CERVICAL FUSION DURING A 12-YEAR PERIOD FROM JANUARY 1998 TO DECEMBER 2009, USING EITHER CANNULATED MAGERL SCREWS OR A MULTIAXIAL PEDICLE SCREW¿ROD SYSTEM, WERE REVIEWED RETROSPECTIVELY AFTER AN AVERAGE FOLLOW-UP PERIOD OF MORE THAN 3 YEARS, AND THE RATE AND CHARACTERISTICS OF THE FAILURE OF THESE IMPLANTS WERE EVALUATED. FORTY ONE PATIENTS WERE IMPLANTED WITH OASYS IMPLANTS. IT WAS REPORTED THAT PATIENT 6 EXPERIENCED AN OASYS "SCREW DISASSEMBLY" AT LEFT TH2 6 MONTHS POST-OPERATIVELY. SPECIFICALLY, THE OASYS BLOCKER MIGRATED FROM IT'S RESPECTIVE SCREW AS EVIDENT FROM X-RAY IMAGING. THE PATIENT THEN REPORTED A "CLATTERY NOISE" IN THEIR NECK 5 MONTHS AFTER THE IMPLANT FAILURE. AN X-RAY SHOWED SUBSEQUENT BREAKAGE OF THE BILATERAL OCCIPITAL PLATE. REVISION SURGERY WAS NOT REQUIRED BECAUSE HER SYMPTOMS WERE MILD. THIS REPORT CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562660 ↗
• InjurySep 24, 2021Migration; Migration

  IT WAS REPORTED THAT A PATIENT RECEIVED REVISION SURGERY TO EXPLANT 2 OASYS BLOCKERS AND 2 RODS WHICH HAD MIGRATED POST-OPERATIVELY FROM AN OCCIPITAL PLATE. THIS REPORT CAPTURES THE SECOND OF THE TWO BLOCKERS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529810 ↗
• InjurySep 24, 2021Migration; Migration

  IT WAS REPORTED THAT A PATIENT RECEIVED REVISION SURGERY TO EXPLANT 2 OASYS BLOCKERS AND 2 RODS WHICH HAD MIGRATED POST-OPERATIVELY FROM AN OCCIPITAL PLATE. THIS REPORT CAPTURES THE FIRST OF THE TWO BLOCKERS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529643 ↗
• InjurySep 17, 2021Migration; Migration

  THE ARTICLE 'ROD MIGRATION TO THE THORACIC SUBARACHNOID SPACE AFTER C1¿2 INSTRUMENTATION: A CASE REPORT AND LITERATURE REVIEW' IN ORTHOPAEDIC SURGERY, VOLUME 9 (129-132) 2017, WAS REVIEWED. IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS TWO MIGRATED OASYS BLOCKERS AND ONE MIGRATED OASYS ROD. THE PATIENT WAS ADMITTED TO THE OUTPATIENT DEPARTMENT WITH SPASTIC TETRAPARESIS AS A SEQUEL TO PEDIATRIC MENINGITIS. THEY HAD NO HISTORY OF ADDITIONAL SYSTEMIC DISEASE. AFTER HAVING BEEN DIAGNOSED WITH C1-C2 CERVICAL SUBLUXATION AND MYELOMALACIA USING CERVICAL MAGNETIC RESONANCE IMAGING (MRI), THE PATIENT UNDERWENT LAMINECTOMY OF C1, AND THE C1 LATERAL MASS AND C2 WERE FIXED USING BILATERAL OASYS PEDICULAR SCREWS ON 20 JUNE 2011. POSTOPERATIVELY THE PATIENT'S COMPLAINTS WERE RESOLVED AND NO RADIOLOGICAL OR ADDITIONAL NEUROLOGICAL FINDINGS WERE IDENTIFIED DURING THEIR FOLLOW-UP PERIOD. AT THE END OF THE THIRD POST-OPERATIVE YEAR, THE PATIENT PRESENTED WITH COMPLAINTS OF HEADACHE, NECK PAIN AND WALKING DIFFICULTY. PHYSICAL EXAMINATION REVEALED TETRAPARESIS WITH 4/5 MUSCLE STRENGTH. THERE WAS NO HISTORY OF TRAUMA DURING THAT PERIOD. ON THE RADIOLOGICAL EVALUATION, THE LEFT ROD WAS NOT DET

  Patient problems: Ambulation or Postural Difficulties; Headache; Neck Pain

  MAUDE report 12487553 ↗
• InjurySep 16, 2021Migration; Migration

  THE ARTICLE 'ROD MIGRATION TO THE THORACIC SUBARACHNOID SPACE AFTER C12 INSTRUMENTATION: A CASE REPORT AND LITERATURE REVIEW' IN ORTHOPAEDIC SURGERY, VOLUME 9 (129-132) 2017, WAS REVIEWED. IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS TWO MIGRATED OASYS BLOCKERS AND ONE MIGRATED OASYS ROD. THE PATIENT WAS ADMITTED TO THE OUTPATIENT DEPARTMENT WITH SPASTIC TETRAPARESIS AS A SEQUEL TO PEDIATRIC MENINGITIS. THEY HAD NO HISTORY OF ADDITIONAL SYSTEMIC DISEASE. AFTER HAVING BEEN DIAGNOSED WITH C1-C2 CERVICAL SUBLUXATION AND MYELOMALACIA USING CERVICAL MAGNETIC RESONANCE IMAGING (MRI), THE PATIENT UNDERWENT LAMINECTOMY OF C1, AND THE C1 LATERAL MASS AND C2 WERE FIXED USING BILATERAL OASYS PEDICULAR SCREWS ON (B)(6) 2011. POSTOPERATIVELY THE PATIENT'S COMPLAINTS WERE RESOLVED AND NO RADIOLOGICAL OR ADDITIONAL NEUROLOGICAL FINDINGS WERE IDENTIFIED DURING THEIR FOLLOW-UP PERIOD. AT THE END OF THE THIRD POST-OPERATIVE YEAR, THE PATIENT PRESENTED WITH COMPLAINTS OF HEADACHE, NECK PAIN AND WALKING DIFFICULTY. PHYSICAL EXAMINATION REVEALED TETRAPARESIS WITH 4/5 MUSCLE STRENGTH. THERE WAS NO HISTORY OF TRAUMA DURING THAT PERIOD. ON THE RADIOLOGICAL EVALUATION, THE LEFT ROD WAS NOT DETE

  Patient problems: Ambulation or Postural Difficulties; Headache; Neck Pain

  MAUDE report 12485478 ↗
• MalfunctionMay 3, 2021Migration; Migration

  IT WAS REPORTED THAT AN OASYS SET SCREW MIGRATED POST-OPERATIVELY. THE SURGEON HAS NO PLAN TO REVISE THE PATIENT AND WILL CONTINUE TO MONITOR THEM INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761033 ↗
• InjuryJul 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN OASYS BLOCKER WAS OBSERVED TO BE STRIPPED ON AN MRI ONE YEAR POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED AND THE BLOCKER HAS BEEN REMOVED.

  Patient problems: Injury

  MAUDE report 10283337 ↗
• InjuryJun 26, 2020Migration; Migration

  UPON PRODUCT RETURN, 8 ADDITIONAL OASYS BLOCKERS WERE RECEIVED AND REVIEWED. AFTER INSPECTION, IT WAS DETERMINED THAT THE BLOCKERS SHOWED SIGNS OF UNDER TIGHTENING INTRA-OPERATIVELY AND MOST LIKELY HAD CONTRIBUTED TO THE ADVERSE EVENTS CAPTURED IN 0009617544-2020-00035 AND 0009617544-2020-00036. THIS REPORT REPRESENTS THE EIGHTH OF EIGHT BLOCKERS.

  Patient problems: Injury

  MAUDE report 10202443 ↗
• InjuryJun 26, 2020Migration; Migration

  UPON PRODUCT RETURN, 8 ADDITIONAL OASYS BLOCKERS WERE RECEIVED AND REVIEWED. AFTER INSPECTION, IT WAS DETERMINED THAT THE BLOCKERS SHOWED SIGNS OF UNDER TIGHTENING INTRA-OPERATIVELY AND MOST LIKELY HAD CONTRIBUTED TO THE ADVERSE EVENTS CAPTURED IN 0009617544-2020-00035 AND 0009617544-2020-00036. THIS REPORT REPRESENTS THE SEVENTH OF EIGHT BLOCKERS.

  Patient problems: Injury

  MAUDE report 10202322 ↗
• InjuryJun 26, 2020Migration; Migration

  UPON PRODUCT RETURN, 8 ADDITIONAL OASYS BLOCKERS WERE RECEIVED AND REVIEWED. AFTER INSPECTION, IT WAS DETERMINED THAT THE BLOCKERS SHOWED SIGNS OF UNDER TIGHTENING INTRA-OPERATIVELY AND MOST LIKELY HAD CONTRIBUTED TO THE ADVERSE EVENTS CAPTURED IN 0009617544-2020-00035 AND 0009617544-2020-00036. THIS REPORT REPRESENTS THE SIXTH OF EIGHT BLOCKERS.

  Patient problems: Injury

  MAUDE report 10202316 ↗
• InjuryJun 26, 2020Migration; Migration

  UPON PRODUCT RETURN, 8 ADDITIONAL OASYS BLOCKERS WERE RECEIVED AND REVIEWED. AFTER INSPECTION, IT WAS DETERMINED THAT THE BLOCKERS SHOWED SIGNS OF UNDER TIGHTENING INTRA-OPERATIVELY AND MOST LIKELY HAD CONTRIBUTED TO THE ADVERSE EVENTS CAPTURED IN 0009617544-2020-00035 AND 0009617544-2020-00036. THIS REPORT REPRESENTS THE FIFTH OF EIGHT BLOCKERS.

  Patient problems: Injury

  MAUDE report 10202314 ↗
• InjuryJun 26, 2020Migration; Migration

  UPON PRODUCT RETURN, 8 ADDITIONAL OASYS BLOCKERS WERE RECEIVED AND REVIEWED. AFTER INSPECTION, IT WAS DETERMINED THAT THE BLOCKERS SHOWED SIGNS OF UNDER TIGHTENING INTRA-OPERATIVELY AND MOST LIKELY HAD CONTRIBUTED TO THE ADVERSE EVENTS CAPTURED IN 0009617544-2020-00035 AND 0009617544-2020-00036. THIS REPORT REPRESENTS THE FOURTH OF EIGHT BLOCKERS.

  Patient problems: Injury

  MAUDE report 10201518 ↗
• InjuryJun 24, 2020Migration; Migration

  UPON PRODUCT RETURN, 3 ADDITIONAL OASYS BLOCKERS WERE RECEIVED AND REVIEWED. AFTER INSPECTION, IT WAS DETERMINED THAT THE BLOCKERS SHOWED SIGNS OF UNDER TIGHTENING INTRA-OPERATIVELY AND MOST LIKELY HAD CONTRIBUTED TO THE ADVERSE EVENTS CAPTURED IN 0009617544-2020-00035 AND 0009617544-2020-00036. THIS REPORT REPRESENTS THE THIRD OF THREE BLOCKERS.

  Patient problems: Injury

  MAUDE report 10190021 ↗
• InjuryJun 24, 2020Migration; Migration

  UPON PRODUCT RETURN, 3 ADDITIONAL OASYS BLOCKERS WERE RECEIVED AND REVIEWED. AFTER INSPECTION, IT WAS DETERMINED THAT THE BLOCKERS SHOWED SIGNS OF UNDER TIGHTENING INTRA-OPERATIVELY AND MOST LIKELY HAD CONTRIBUTED TO THE ADVERSE EVENTS CAPTURED IN 0009617544-2020-00035 AND 0009617544-2020-00036. THIS REPORT REPRESENTS THE SECOND OF THREE BLOCKERS.

  Patient problems: Injury

  MAUDE report 10190005 ↗
• InjuryMar 9, 2020Migration; Migration

  UPON PRODUCT RETURN, IT WAS DETERMINED THAT THE BLOCKER SHOWED SIGNS OF UNDER TIGHTENING INTRA-OPERATIVELY AND MOST LIKELY HAD CONTRIBUTED TO THE ADVERSE EVENTS CAPTURED IN 0009617544-2020-00035 AND 0009617544-2020-00036. THIS REPORT REPRESENTS THE FIRST OF THREE BLOCKERS.

  Patient problems: Injury

  MAUDE report 9808684 ↗
• MalfunctionFeb 6, 2020Fracture; Migration; Fracture; Migration

  A PHYSICIAN REPORTED THAT AN OASYS BLOCKER FAILED POST-OPERATIVELY AS SEEN ON X-RAY IMAGING. THE BLOCKER DISENGAGED FROM ITS RESPECTIVE SCREWS. NO REVISION IS PLANNED AT THIS TIME. THIS RECORD REPRESENTS BLOCKER 5 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678434 ↗
• MalfunctionFeb 6, 2020Fracture; Migration; Fracture; Migration

  A PHYSICIAN REPORTED THAT AN OASYS BLOCKER FAILED POST-OPERATIVELY AS SEEN ON X-RAY IMAGING. THE BLOCKER DISENGAGED FROM ITS RESPECTIVE SCREWS. NO REVISION IS PLANNED AT THIS TIME. THIS RECORD REPRESENTS BLOCKER 4 OF 5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9678433 ↗
• MalfunctionFeb 6, 2020Fracture; Migration; Fracture; Migration

  A PHYSICIAN REPORTED THAT AN OASYS BLOCKER CONSTRUCT FAILED POST-OPERATIVELY AS SEEN ON X- RAY IMAGING. REVISION SURGERY HAS NOT BEEN REPORTED. THIS RECORD REPRESENTS PART 2 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678428 ↗
• MalfunctionFeb 6, 2020Fracture; Migration; Fracture; Migration

  A PHYSICIAN REPORTED THAT AN OASYS BLOCKER FAILED POST-OPERATIVELY AS SEEN ON X-RAY IMAGING. THE BLOCKER DISENGAGED FROM ITS RESPECTIVE SCREWS. NO REVISION IS PLANNED AT THIS TIME. THIS RECORD REPRESENTS BLOCKER 3 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678427 ↗