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INFINITY™ Occipitocervical Upper Thoracic System 3604012Recalls & reported problems

Medtronic Sofamor Danek, Inc. · MULTI AXIAL SCREW 3604012 4.0 X 12MM · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169554627), received between Feb 26, 2020 and Feb 26, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (6 reports).

5 other recalls cover devices cleared under the same FDA submission (K163375); they may or may not involve this specific model.

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

  • Migration6

Patient problems

  • Injury6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 26, 2020Migration; Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION (PCF) FROM C3 TO T2. POST-OP, THE LATERAL MASS SCREWS PULLED OUT OF C3, C4, AND C5. THIS LEFT THE PATIENT'S NECK UNSTABLE. THE SURGEON SAID THAT THE PATIENT DID NOT FALL AND HAS BEEN WEARING A COLLAR THROUGHOUT POST-OP RECOVERY. THE PATIENT WILL REQUIRE REVISION SURGERY AS A RESULT OF THIS EVENT ON A LATER DATE.

    Patient problems: Injury

    MAUDE report 9754863 ↗
  • InjuryFeb 26, 2020Migration; Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION (PCF) FROM C3 TO T2. POST-OP, THE LATERAL MASS SCREWS PULLED OUT OF C3, C4, AND C5. THIS LEFT THE PATIENT'S NECK UNSTABLE. THE SURGEON SAID THAT THE PATIENT DID NOT FALL AND HAS BEEN WEARING A COLLAR THROUGHOUT POST-OP RECOVERY. THE PATIENT WILL REQUIRE REVISION SURGERY AS A RESULT OF THIS EVENT ON A LATER DATE.

    Patient problems: Injury

    MAUDE report 9754856 ↗
  • InjuryFeb 26, 2020Migration; Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION (PCF) FROM C3 TO T2. POST-OP, THE LATERAL MASS SCREWS PULLED OUT OF C3, C4, AND C5. THIS LEFT THE PATIENT'S NECK UNSTABLE. THE SURGEON SAID THAT THE PATIENT DID NOT FALL AND HAS BEEN WEARING A COLLAR THROUGHOUT POST-OP RECOVERY. THE PATIENT WILL REQUIRE REVISION SURGERY AS A RESULT OF THIS EVENT ON A LATER DATE.

    Patient problems: Injury

    MAUDE report 9754849 ↗
  • InjuryFeb 26, 2020Migration; Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION (PCF) FROM C3 TO T2. POST-OP, THE LATERAL MASS SCREWS PULLED OUT OF C3, C4, AND C5. THIS LEFT THE PATIENT'S NECK UNSTABLE. THE SURGEON SAID THAT THE PATIENT DID NOT FALL AND HAS BEEN WEARING A COLLAR THROUGHOUT POST-OP RECOVERY. THE PATIENT WILL REQUIRE REVISION SURGERY AS A RESULT OF THIS EVENT ON A LATER DATE.

    Patient problems: Injury

    MAUDE report 9754848 ↗
  • InjuryFeb 26, 2020Migration; Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION (PCF) FROM C3 TO T2. POST-OP, THE LATERAL MASS SCREWS PULLED OUT OF C3, C4, AND C5. THIS LEFT THE PATIENT'S NECK UNSTABLE. THE SURGEON SAID THAT THE PATIENT DID NOT FALL AND HAS BEEN WEARING A COLLAR THROUGHOUT POST-OP RECOVERY. THE PATIENT WILL REQUIRE REVISION SURGERY AS A RESULT OF THIS EVENT ON A LATER DATE.

    Patient problems: Injury

    MAUDE report 9754833 ↗
  • InjuryFeb 26, 2020Migration; Migration

    THE REVISION SURGERY TOOK PLACE ON (B)(6) 2020. THE REVISION SURGERY WENT WELL, AND THE SURGEON WAS ABLE TO ANCHOR NEW SCREWS FOR A STRONGER CONSTRUCT. WE HAVE NOT HEARD OF ANY COMPLICATIONS SINCE THE REVISION.

    Patient problems: Injury

    MAUDE report 9754687 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163375. One submission often covers many models, so check the product and lot details in each record.

  • Z-1410-2023 · Feb 16, 2023 · Open, Classified
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion
  • Z-1412-2023 · Feb 16, 2023 · Open, Classified
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion
  • Z-1409-2023 · Feb 16, 2023 · Open, Classified
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion
  • Z-1411-2023 · Feb 16, 2023 · Open, Classified
    INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as
  • Z-1413-2023 · Feb 16, 2023 · Open, Classified
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion

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Sources and updates

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