CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016540Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169501072), received between Aug 21, 2017 and Jun 4, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN SPINAL FUSION THERAPY. IT WAS REPORTED THAT WHEN THE SCREW WAS OPENED AND THEN ATTACHED TO THE TAB EXTENDER, THE TAB OF THE SCREW WAS BENT, SO IT COULD NOT BE ATTACHED. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456443 ↗
• InjuryJan 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN THE REPORTED EVENT. LEVELS IMPLANTED: T10-L5. IT WAS REPORTED THAT THEY PERFORMED VERTEBRAL BODY REPLACEMENT AND POSTERIOR FUSION OF T11.12.L2 FOR L1 BURST. AFTER THAT, THE T3 VERTEBRAL BODY REPLACEMENT CAGE SUNK TO THE L2 VERTEBRAL BODY, AND AT THE SAME TIME, THE L2 SCREW BACKED OUT. THE L2 SCREW WAS REMOVED AND SINCE THERE WAS BKP IN L3, SCREW WAS ADDED TO L4.5 AND T10 TO EXTEND AND RE-FIXED. THERE WAS NO MALFUNCTION WITH THE PRODUCTS. PATIENT SYMPTOMS- DORSAL PAIN WAS REPORTED. PATIENT WAS HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 13169031 ↗
• InjuryJan 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN THE REPORTED EVENT. LEVELS IMPLANTED: T10-L5. IT WAS REPORTED THAT THEY PERFORMED VERTEBRAL BODY REPLACEMENT AND POSTERIOR FUSION OF T11.12.L2 FOR L1 BURST. AFTER THAT, THE T3 VERTEBRAL BODY REPLACEMENT CAGE SUNK TO THE L2 VERTEBRAL BODY, AND AT THE SAME TIME, THE L2 SCREW BACKED OUT. THE L2 SCREW WAS REMOVED AND SINCE THERE WAS BKP IN L3, SCREW WAS ADDED TO L4.5 AND T10 TO EXTEND AND RE-FIXED. THERE WAS NO MALFUNCTION WITH THE PRODUCTS. PATIENT SYMPTOMS- DORSAL PAIN WAS REPORTED. PATIENT WAS HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 13168956 ↗
• InjuryAug 23, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION (OLIF) OF 3 INTERVERTEBRAL DISCS AT L2-3, L3-4, L4-5 DUE TO UNKNOWN REASON.POST-OP, THE SCREW LOOSENING HAD OCCURRED. HENCE ON (B)(6) 2019, REVISION SURGERY WAS PERFORMED AND THE SCREWS AT L2-3-4-5 WERE REMOVED AND REPLACED AND FUSION FOR EXTENDING WAS PERFORMED UP TO S1, S2AI. THE PATIENT COMPLAINTS ABOUT PAIN BETWEEN L4 AND L5 INTERVERTEBRAL DISC SPACE. INFECTION OCCURRED TO THE INTERVERTEBRAL DISC SPACE BETWEEN L4 AND L5 AND THE PEDICLE ON THE RIGHT SIDE OF L5.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8924892 ↗
• InjuryJul 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FIXATION OF L4-S1 AND POSTERIOR LUMBAR INTERBODY FUSION OF L5-S1; DUE TO DEGENERATIVE SPONDYLOLISTHESIS AND INTERVERTEBRAL DISC HERNIATION. ON AN UNKNOWN DATE, POST-OP, THE SCREW AT LEFT OF S1 LOOSENED. DUE TO THIS, THE PATIENT EXPERIENCED LOWER LIMB PAIN AND HAD PSEUDOARTHROSIS. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY; IN WHICH SCREWS ON THE LEFT OF L4-L5-S1 AND THE RIGHT OF S1 WERE REPLACED AND BONE GRAFT WAS PERFORMED AGAIN. PATIENT'S ISSUE HAS NOW BEEN REPORTED AS RESOLVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8781420 ↗
• MalfunctionOct 23, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION SURGERY AT 1A-1B LEVELS. POST-OPERATIVELY, THE SCREW GOT LOOSE. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND THE SCREW WAS EXPLANTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994245 ↗
• MalfunctionOct 23, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION SURGERY AT 1A-1B LEVELS. POST-OPERATIVELY, THE SCREW GOT LOOSE. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND THE SCREW WAS EXPLANTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994242 ↗
• MalfunctionOct 23, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION SURGERY AT 1A-1B LEVELS. POST-OPERATIVELY, THE SCREW GOT LOOSE. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND THE SCREW WAS EXPLANTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994218 ↗
• MalfunctionOct 23, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION SURGERY AT 1A-1B LEVELS. POST-OPERATIVELY, THE SCREW GOT LOOSE. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND THE SCREW WAS EXPLANTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994210 ↗
• MalfunctionOct 23, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION SURGERY AT 1A-1B LEVELS. POST-OPERATIVELY, THE SCREW GOT LOOSE. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND THE SCREW WAS EXPLANTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994201 ↗
• MalfunctionSep 26, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION SURGERY AT 1A-1B LEVELS. POST-OPERATIVELY, THE SCREW GOT LOOSE. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND THE SCREW WAS EXPLANTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7908929 ↗
• InjuryAug 21, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT T12,L1 VERTEBRECTOMY,VERTEBRAL BODY REPLACEMENT SYSTEM WAS PLACED AND SCREWS WERE INSERTED AT T10,T11 AND L2. POST OP, ON AN UNKNOWN DATE, L2 SCREW LOOSENING WAS OBSERVED FOR WHICH PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 AND FIXATION WAS EXTENDED.IN THE REVISION SURGERY AFTER REMOVING SCREW, SPINAL FUSION WAS PERFORMED AT T8/IL.POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AT L5/S1. SURGEON COMMENTED THAT INITIAL FIXATION RANGE WAS TOO SHORT AND THE PATIENT¿S BONE QUALITY WAS POOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6806659 ↗