INFINITY™ Occipitocervical Upper Thoracic System 3600315Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169541962), received between Sep 21, 2020 and Apr 12, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL STENOSIS C3-T1 FOR C3-T1 LAMINECTOMIES AND POSTERIOR FUSION. IT WAS REPORTED THAT INTRA-OPERATIVELY, UPON FINAL TIGHTENING OF THE SET SCREWS, A FEW OF THEM WOULD NOT REACH THE TORQUE LIMITING CLICK FEATURE WHEN USING THE SCREWDRIVERS. THE STRIPPED SET SCREWS WERE REMOVED AND REPLACED WITH NEW SET SCREWS. SET SCREWS WEREN¿T IN DIRECT CONTACT WITH THE PATIENT BUT ARE IN CONTACT WITH THE SCREW AND ROD CONSTRUCT THAT ARE TOUCHING THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649211 ↗
• MalfunctionApr 12, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL STENOSIS C3-T1 FOR C3-T1 LAMINECTOMIES AND POSTERIOR FUSION. IT WAS REPORTED THAT INTRA-OPERATIVELY, UPON FINAL TIGHTENING OF THE SET SCREWS, A FEW OF THEM WOULD NOT REACH THE TORQUE LIMITING CLICK FEATURE WHEN USING THE SCREWDRIVERS. THE STRIPPED SET SCREWS WERE REMOVED AND REPLACED WITH NEW SET SCREWS. SET SCREWS WEREN¿T IN DIRECT CONTACT WITH THE PATIENT BUT ARE IN CONTACT WITH THE SCREW AND ROD CONSTRUCT THAT ARE TOUCHING THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649155 ↗
• MalfunctionJan 4, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT INTRA-OP, SHAFT AND SET SCREW STRIPPED ON FINAL TIGHTENING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106397 ↗
• MalfunctionJan 4, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT INTRA-OP, SHAFT AND SET SCREW STRIPPED ON FINAL TIGHTENING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106394 ↗
• MalfunctionJan 4, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT INTRA-OP, SHAFT AND SET SCREW STRIPPED ON FINAL TIGHTENING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106335 ↗
• InjuryDec 11, 2020Expulsion; Expulsion

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY BEEN TREATED BY A DIFFERENT SPINE SURGEON FOR AN ACDF AND THEN A C3 TO C7 POSTERIOR CERVICAL FUSION. THE CERVICAL PLATE WAS VERY MAL PLACED AND THE POSTERIOR CERVICAL CONSTRUCT FAILED. THE PATIENT WAS TOLD BY THE PR EVIOUS SURGEON THAT THERE WAS NOTHING MORE THAT THEY COULD DO FOR THEM AND THAT IS WHEN THE PATIENT WENT TO SEE CURRENT DOCTOR. THE PATIENT WAS RE-OPERATED ON THE POSTERIOR CERVICAL FUSION. DOCTOR EXTENDED THE CONSTRUCT TO INCLUDE C2 AND T1. THE PATIENT RETURNED DOCTOR WITH NECK PAIN AND FILMS SHOWED THAT THE TWO SET SCREWS IN C2 POPPED OFF OR BACKED OUT, THE ONE SCREW IN C3 RIGHT SIDE PULLED OUT SO DOCTOR SCHEDULED REVISION TO REMOVE THE SCREWS IN C5 AND C6, PUT A NEW SHORTER ROD IN C7TO T1, LEAVING THE SCREWS WHICH WERE WELL FIXED IN C2 AND C4. HE THEN CLOSED THE POSTERIORSIDE AND FLIPPED THE PATIENT. ON THE ANTERIOR SIDE HE REMOVED THE OLD MAL-POSITIONED PLATE, AND THEN PERFORMED AN ACDF FROM C2 TO C4 USING A ZEVO PLATE AND SCREWS.THE SET SCREW EITHER B

  Patient problems: Neck Pain

  MAUDE report 10990702 ↗
• MalfunctionNov 3, 2020Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL THERAPY. IT WAS REPORTED THAT SURGEON STATED THE METAL IS "TOO SOFT" AND STRIPS TOO EASY. THIS ITEM WAS STRIPPED. THE TORQUE SHAFT WAS USED WITH THE SET SCREW. ALSO SURGEON REDUCED THE ROD BUT WAS UNABLE TO ENGAGE SET SCREW INTO SCREW. HE COMMENTED THAT THE ALIGNMENT SEEMS OFF . THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10776607 ↗
• MalfunctionSep 21, 2020Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH UNKNOWN INDICATION FOR C3-C5 FUSION. IT WAS REPORTED THAT SET SCREWS STRIPPED WHEN TORQUING. INTERFACE BETWEEN DRIVER TIP AND SET SCREW STRIPPED, EDGES ROUNDED OFF AND COULD NOT TORQUE SCREWS, NEW SHAFT WAS USED TO COMPLETE PROCEDURE. ONE SET SCREW REMOVED AND REPLACED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PRODUCT WILL BE RETURNED AND REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10559250 ↗

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-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-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
• 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-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