Response Spine 5.5/6.0 System 00-1003-4001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841132100103), received between May 1, 2019 and Jun 2, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Migration

  PATIENT PRESENTED IN CLINIC 1 YEAR POST OP AND FOUND MULTIPLE SET SCREWS DISENGAGED.

  Patient problems: Failure of Implant

  MAUDE report 25364722 ↗
• MalfunctionMay 21, 2026Migration

  A POST-OPERATIVE DEVICE-RELATED ISSUE WAS IDENTIFIED IN A PATIENT WHO UNDERWENT SPINAL SURGERY ON (B)(6) 2024, UTILIZING A RESPONSE 5.5/6.0 SCOLIOSIS SYSTEM. THE IMPLANTED DEVICE INCLUDED A LARGE SET SCREW (PART NUMBER: 00-1003-4001). ON (B)(6) 2026, DURING A ROUTINE CLINIC FOLLOW-UP VISIT, THE PATIENT PRESENTED WITH A DISENGAGED SET SCREW. THE EVENT WAS DISCOVERED IN A POST-OPERATIVE CLINICAL SETTING. THERE WAS NO REPORTED DEATH OR PATIENT INJURY ASSOCIATED WITH THIS EVENT; HOWEVER, THE DISENGAGEMENT RESULTED IN THE FAILURE OF THE ORIGINAL SURGICAL CONSTRUCT. AS A RESULT OF THIS DEVICE ISSUE, A REVISION SURGERY HAS BEEN DEEMED NECESSARY, AND SCHEDULING IS PENDING. AT THIS TIME THE DEVICE REMAINS IMPLANTED IN THE PATIENT, AND THEREFORE, NO PRODUCT IS CURRENTLY AVAILABLE FOR RETURN OR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 25241560 ↗
• MalfunctionMar 24, 2026Migration

  PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2025. IN POST OP FILMS BACK IN (B)(6), NO ISSUES SEEN. FOLLOW-UP VISIT WHEN KID SHOWED UP AT CLINIC, AT LEAST 5 SET SCREWS DISENGAGED ON RIGHT SIDE. 6.0.

  Patient problems: Failure of Implant

  MAUDE report 24681790 ↗
• MalfunctionJul 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  KYPHOSIS CASE DONE AROUND 4 YEARS AGO. PATIENT PRESENTS WITH BROKEN ROD. DURING REVISION, SURGEONS TRY TO EXTEND 1 LEVEL BILATERAL BUT SURGEON BLOWS PEDICLE ON R SO ONLY EXTEND ON L BUT REPLACE RODS. DURING REDUCTION, A LOT OF LORDOSIS IN ROD. PATIENT COMES BACK LESS THAN WEEK LATER WITH SET SCREW DISENGAGED ON THE EXTENDED LEVEL. ADD SIDE BY SIDE TO R SIDE AND REPLACE DISENGAGED SET SCREW.

  Patient problems: Failure of Implant

  MAUDE report 22490284 ↗
• MalfunctionJun 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6), DR. (B)(6) STARTED TO IMPLANT RESPONSE 6.0 INTO A PATIENT. DUE TO PATIENT HEALTH ISSUES THE CASE WAS ABORTED WITH ABOUT HALF THE SCREWS IMPLANTED. HE THEN CAME BACK ON (B)(6) AND COMPLETED THE SURGERY WHICH INCLUDED LEVELS T2 TO L2. ON (B)(6), DR. (B)(6) REVISED THE PATIENT DUE TO THE LOWER SET SCREWS HAVING FALLEN OUT. AFTER EXPOSING HE FOUND THAT NINE OF THE LOWER 10 SET SCREWS WERE LOOSE OR MISSING. HE WAS VERY CONCERNED ABOUT THE SCREWS LOOSENING FARTHER PROXIMAL IN THE CONSTRUCT. HE SAID HE UNDERSTANDS THE BOTTOM TO LOOSENING, BUT DID NOT UNDERSTAND WHY THEY LOOSENED THE REST OF THE WAY UP. HE WOULD LIKE TO TALK TO SOMEBODY ABOUT TESTING WHETHER BURNING OR CUTTING THE ROD INSITU HAS THE POTENTIAL TO LOOSEN THE ROD.

  Patient problems: Failure of Implant

  MAUDE report 22290319 ↗
• MalfunctionFeb 7, 2025Mechanical Problem; Mechanical Problem

  SURGEON NOTICED THAT SET SCREWS HAD BACK OUTED AND HAS SUBSEQUENTLY REVISED . THIS WAS SURGEONS FIRST CASE EITHER RESPONSE, AND DID NOT USE THE REDUCTION TOWER AT THE BOTTOM OF THE CONSTRUCT. HANDLES TORQUE WERE RETURNED AND FOUND TO BE IN CALIBRATION.

  Patient problems: Insufficient Information

  MAUDE report 21333255 ↗
• InjuryFeb 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT APPROXIMATELY THREE YEARS FOLLOWING THE PLACEMENT OF A RESPONSE SPINAL CONSTRUCT, THE PATIENT UNDERWENT A REVISION DUE TO ROD FRACTURE AND LOOSE SET SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9738473 ↗
• InjuryFeb 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT APPROXIMATELY THREE YEARS FOLLOWING THE PLACEMENT OF A RESPONSE SPINAL CONSTRUCT, THE PATIENT UNDERWENT A REVISION DUE TO ROD FRACTURE AND LOOSE SET SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9738456 ↗
• InjuryMay 1, 2019Fracture; Fracture

  IT WAS REPORTED THAT FOLLOWING A POSTERIOR FUSION SURGERY, THE PATIENT EXPERIENCED BACK PAIN AND CLICKING. IT WAS DISCOVERED DURING THE REVISION PROCEDURE THAT A SET SCREW WAS LOOSE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8571189 ↗