Minimally Invasive Deformity Correction (MID-C) System MID-C 105Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07290018128022), received between Sep 13, 2022 and Jan 22, 2025 — classified as 1 injury, 11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON DECEMBER 27, 2024, APIFIX WAS NOTIFIED THAT PATIENT # (B)(6); (PAS # (B)(6) UNDERWENT A REMOVAL SURGERY ON (B)(6) 2024, FOR REASONS THAT WERE INITIALLY UNSPECIFIED. APIFIX PROMPTLY FOLLOWED UP WITH THE REPORTER TO INQUIRE ABOUT THE RATIONALE FOR THE REMOVAL. THE REPORTER CLARIFIED THAT PATIENT # (B)(6) WAS CONSIDERED A "GRADUATE" OF THE APIFIX DEVICE. THE SURGEON DETERMINED THAT THE DEVICE WAS NO LONGER NECESSARY TO MAINTAIN CORRECTION BECAUSE THE PATIENT WAS SKELETALLY MATURE AND HAD REACHED THE 3-YEAR POSTOPERATIVE MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21205789 ↗
• MalfunctionOct 15, 2024Unintended Movement; Unintended Movement

  ON (B)(6) 2024 DURING MONITORING OF THE PAS, APIFIX IDENTIFIED THAT PATIENT # (B)(6) REPORTEDLY HAS A RATCHETING SYSTEM THAT SHORTENED IN LENGTH WHEN COMPARED TO PAST FILMS, INDICATIVE OF 'DYSFUNCTION OF THE RATCHET MECHANISM'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451998 ↗
• MalfunctionAug 14, 2024Break; Break

  PATIENT (B)(6) INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2021. ON 17-JUL-2024 APIFIX WAS NOTIFIED THAT PATIENT (B)(6) HAS A BROKEN ROD. IT IS UNSURE AT THIS TIME WHEN A REVISION IS PLANNED FOR OR WHAT THEY PLAN TO DO.

  Patient problems: Pain

  MAUDE report 19981189 ↗
• MalfunctionMay 1, 2024Migration; Migration

  ON 03-APR-2024 APIFIX WAS NOTIFIED THAT PATIENT #890 ((B)(6)) UNDERWENT A REVISION SURGERY ON (B)(6) 2024 TO REPLACE A SCREW THAT HAD MIGRATED.

  Patient problems: Pain

  MAUDE report 19219232 ↗
• MalfunctionApr 10, 2024Migration; Migration

  ON 13-MAR-2024 APIFIX WAS MADE AWARE THAT PATIENT #(B)(6) (PAS# (B)(6)) REPORTEDLY HAS A SCREW WHICH IS MIGRATING. 'IT APPEARS THE SUPERIOR SCREW IS BEGINNING TO PLOW".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079469 ↗
• MalfunctionFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 APIFIX WAS NOTIFIED THAT PATIENT (B)(6) (PAS (B)(6) WHO WAS A PATIENT IN DAYTON IS PLANNED TO BE CONVERTED TO FUSION IN ANOTHER FACILITY (NORTH CAROLINA) BY ANOTHER PHYSICIAN..

  Patient problems: Physical Asymmetry

  MAUDE report 18638599 ↗
• MalfunctionFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING MONITORING, AS PART OF THE PAS STUDY, APIFIX WAS MADE AWARE ON 14-DEC-2023 THAT PATIENT #(B)(6), INDEX PROCEDURE PERFORMED ON (B)(6) 2022, REPORTED RIGHT-SIDED BACK PAIN AT A CLINIC VISIT ON (B)(6) 2023, ACUTE ON CHRONIC RIGHT SIDED BACK PAIN THAT HAS WORSENED OVER LAST SEVERAL MONTHS THAT IS NOW MIGRATING DOWN THE RIGHT SIDE OF THIGH. THE REPORTER INDICATED THAT THE PAIN IS NOT RELATED TO THE DEVICE OR PROCEDURE. APIFIX FOLLOWED UP WITH THE SITE FOR ADDITIONAL INFORMATION WHICH WAS RECEIVED. PATIENT UNDERWENT AN MRI SCAN; 'MODERATE FLUID AND EDEMA WITHIN THE RIGHT PARASPINAL SOFT TISSUES BETWEEN L1 AND L5, SPONDYLOLYSIS GRADE 1 WITH SPONDYLOLISTHESIS L5-S1, MINIMAL DISTENSION OF CENTRAL CANAL IN LOWER SPINAL CORD' WAS OBSERVED. ON 11-JAN-2024 APIFIX WAS NOTIFIED THAT PATIENT #(B)(6) WAS SEEN IN CLINIC ON (B)(6) 2024. FROM DR. ALBERT'S CLINIC NOTES WITH THIS PATIENT, HE HAS CONCERNS ABOUT THE SWELLING ALONG THAT RIGHT SIDE OF THE PATIENT'S SPINE AND THE SPONDYLOLISTHESIS AND SPONDYLOLYSIS, WHICH WERE NOT PRESENT ON THE PRE-OP MRI. DR. ALBERT IS UNSURE IF THESE CHANGES ARE DUE TO A MOTOR VEHICLE ACCIDENT THE PATIENT WAS IN, IN (B)(6) 2023. THERE ARE SOME CONCERNS OF INFECTION

  Patient problems: Implant Pain

  MAUDE report 18638509 ↗
• MalfunctionJan 15, 2024Break; Break

  ON 19-DEC-2023 APIFIX WAS NOTIFIED THAT PATIENT #(B)(6) UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. ACCORDING TO THE REPORTER, AT THE END OF (B)(6) AN X-RAY SHOWED THE APIFIX SCREW AT T12 WAS FRACTURED. THE PATIENT WANTED TO FINISH THEIR SOCCER SEASON BEFORE ADDRESSING THE FRACTURED SCREW. ON (B)(6) 2023, THE SURGEON REMOVED THE APIFIX DEVICE FROM THE PATIENT. ACCORDING TO THE SURGEON, THE PATIENT'S CURVE WAS STABLE ENOUGH THAT ANOTHER APIFIX DEVICE WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510430 ↗
• MalfunctionAug 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 02-AUG-2023 APIFIX WAS NOTIFIED THAT PATIENT (B)(6) IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2023 DUE TO THE PATIENT'S MID-C 105 MAXING OUT. NO REPORT OF PATIENT HARM/COMPLICATIONS WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17659408 ↗
• MalfunctionJul 3, 2023Migration; Migration

  ON (B)(6) 2023 APIFIX WAS NOTIFIED THAT PATIENT #737 IS UNDERGOING REMOVAL SURGERY (TODAY) DUE TO APIFIX DISTAL BOLT LATERAL MIGRATION AND DISLODGEMENT FROM BONE.  PATIENT TO TRANSITION TO MAGEC RODS AS TEMPORIZING DEVICE UNTIL DEFINITIVE FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245610 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 PATIENT (B)(6) PATIENT UNDERWENT A REVISION PROCEDURE, DURING WHICH A BROKEN SCREW WAS REPLACED, ALONG WITH A SHORTER MID-C & A NEW EXTENDER. ON (B)(6) 2023, PATIENT (B)(6) WAS SEEN FOR A POST-OP VISIT. DURING REVISION SURGERY ((B)(6) 2023) THEY CULTURED A FILM BETWEEN THE INNER AND OUTER SLEEVE OF THE APIFIX. AFTER OVER ONE WEEK, THE ANAEROBIC SIDE GREW P. ACNES. THE PATIENT WAS STARTED ON DOXYCYCLINE 100 MG TWICE A DAY.

  Patient problems: Bacterial Infection

  MAUDE report 16377317 ↗
• MalfunctionSep 13, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT #(B)(6) INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT WAS REVISED DUE TO DEVICE MIGRATION; THE KITE ANGLE HAD INCREASED SINCE INITIAL IMPLANT. DURING THE REVISION, "THE SECOND VERTEBRA SCREW WAS REMOVED AND UPSIZED TO A LARGER SCREW. THE 1ST VERTEBRA SCREW REMAINED IN PLACE. THE DISTAL SCREW REMAINED IN PLACE. THE ORIGINAL MID-C WAS EXPLANTED AND REPLACED WITH A NEW LONGER MID-C DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15408563 ↗