Minimally Invasive Deformity Correction (MID-C) System MID-C 115Recalls & reported problems
Apifix Ltd · Class N · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This APIFIX MID-C system is a posterior spinal rod used to correct deformity in the spine. The 29 reports mostly describe the rod breaking after implantation, sometimes at the ratchet area, along with back pain and removal of the implant after the patient finished growing. Reports include 7 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07290018128039), received between Apr 12, 2021 and Jan 27, 2025 — classified as 7 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Break” (11 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.
Reports received per month
Most reported problems
Device problems
- Break11
- Adverse Event Without Identified Device or Use Problem5
- No Apparent Adverse Event4
- Appropriate Device Problem Term/Code Not Available3
- Fracture2
- Migration2
- Biocompatibility1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Pain7
- Failure of Implant5
- Discomfort2
- Fistula1
- Implant Pain1
- Insufficient Information1
- Physical Asymmetry1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2025Fracture; Fracture
ON 30-DEC-2024 APIFIX WAS MADE AWARE THAT PATIENT #(B)(6) THAT HAD AN APIFIX INSERTED FROM T10-L4 IN AUGUST OF 2021 AND HAS BEEN SKELETALLY MATURE FOR OVER 3 YEARS, PRESENTED WITH INCREASING LOW BACK PAIN, PARTICULARLY DURING WORK-RELATED ACTIVITIES LIKE LIFTING AND MOPPING. DOCTOR NOTICED THAT THE ROD IS FRACTURED. IT WAS ALREADY FRACTURED WHEN HE SAW HER IN (B)(6), BUT HE DIDN'T NOTICE IT. THE CONNECTION BETWEEN THE ROD FRACTURE AND HER PAIN IS NOT DEFINITIVE.
Patient problems: Pain
MAUDE report 21238911 ↗MalfunctionJan 19, 2025No Apparent Adverse Event; No Apparent Adverse Event
ON 20-DEC-2024 APIFIX WAS NOTIFED THAT PATIENT #599 UNDERWENT IMPLANT REMOVAL THAT DAY. ACCORDING TO THE REPORTER, THE PATIENT HAS REACHED SKELETAL MATURITY AND WANTS TO HAVE IT REMOVED. THERE ARE NO COMPLICATIONS OR CONCERNS WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187699 ↗MalfunctionDec 30, 2024No Apparent Adverse Event; No Apparent Adverse Event
ON (B)(6) 2024 APIFIX WAS NOTIFIED THAT PATIENT # (B)(6) HAD HIS IMPLANT REMOVED ON (B)(6)2024. ACCORDING TO THE REPORT RECEIVED, 'PLANNED REMOVAL BECAUSE OF SKELETAL MATURITY. NO PATIENT COMPLAINTS, NO INFECTION, VERY LITTLE METALOSIS. REMOVED IMPLANT WAS INTACT AND RETAINED BY THE PATIENT.'
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21033957 ↗MalfunctionDec 9, 2024Break; Break
ON (B)(6) 2024 APIFIX WAS NOTIFIED THAT AT PATIENT (B)(6) (PAS #091-A023)'S 3 YEAR FOLLOW-UP, X-RAYS SHOWED THAT THE APIFIX ROD WAS BROKEN. THE PATIENT EXPERIENCED POPPING OF THE DEVICE BUT NO BACK PAIN ASSOCIATED WITH IT. THE PATIENT IS SCHEDULED TO HAVE THE DEVICE REMOVED ON (B)(6) 2024
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20876175 ↗MalfunctionDec 2, 2024Break; Break
ON 06-NOV-2024 APIFIX WAS NOTIFIED THAT PATIENT # (B)(6) HEARD A "POP", X-RAYS REVEALED AN IMPLANT BREAKAGE OVER THE RATCHET AREA. THE PLAN IS TO EXPLANT THE DEVICE IN (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20817060 ↗MalfunctionOct 18, 2024No Apparent Adverse Event; No Apparent Adverse Event
ON 20-SEP-2024 APIFIX WAS NOTIFIED THAT PATIENT #517 (PAS #(B)(6)) HAD HER IMPLANT REMOVED THAT DAY. THE REPORTER INDICATED THAT 'THE REMOVAL WAS NOT FOR ANY ISSUES; IT WAS JUST BECAUSE SHE IS FULLY CORRECTED AND SKELETALLY MATURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482798 ↗MalfunctionAug 7, 2024Break; Break
ON 16-JUL-2024 APIFIX WAS MADE AWARE THAT PATIENT # (B)(6) (PAS# 090-A017) WAS SCHEDULED FOR ROD EXCHANGE ON 17-JUL-2024 DUE TO BROKEN ROD (LENKE 5). ON (B)(6) 2024, IT WAS REPORTED THAT THE SURGERY IS BEING POSTPONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19926096 ↗MalfunctionApr 24, 2024Break; Break
ON (B)(6) 2024 APIFIX WAS NOTIFIED THAT PATIENT (B)(6) (PAS (B)(6) IS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2024. REASONS FOR DEVICE REMOVAL: "CURVE PROGRESSION AND PERI-IMPLANT PAIN AND DISCOMFORT."
Patient problems: Discomfort; Pain
MAUDE report 19170565 ↗MalfunctionMar 10, 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 08-FEB-2024 THAT PATIENT (B)(6) ((B)(4)), INDEX PROCEDURE PERFORMED ON (B)(6) 2022, REPORTED PROMINENCE OF INSTRUMENTATION CAUSING DISCOMFORT (NOTED ON 12/29/2023). ACCORDING TO THE REPORT, THE PATIENT HAD GENERALIZED BACK PAIN WITH PAIN INTO BOTH LEGS (SEEN ON (B)(6) 2023 WITH C/O GENERALAIZED BACK PAIN). IT WAS FURTHER REPORTED THAT THE PAIN IN LEGS WAS BEFORE AND AFTER PROCEDURE (AGGRAVATION OF A PRE-OP KNOWN CONDITION). SCHROTH PHYSICAL THERAPY WAS ATTEMPTED THAT DID NOT GIVE RELIEF; SHE WAS THEN REFERRED TO A PAIN CLINIC FOR PAIN MANAGEMENT PLAN; NEW PT RX WAS GIVEN ON (B)(6) 2023 TO CONCENTRATE ON HIPS AND SHOULDERS THAT DID NOT OFFER MUCH RELIEF. ON (B)(6) 2024 APIFIX WAS NOTIFIED THAT PATIENT (B)(6) ((B)(4)) UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. ACCORDING TO THE REPORTER, "PATIENTS BONE QUALITY WAS NOT GREAT. SURGEON IS SUSPICIOUS OF A POSSIBLE UNDERLYING SOFT TISSUE DISORDER."
Patient problems: Pain
MAUDE report 18871938 ↗InjuryMar 6, 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 08-FEB-2024 THAT PATIENT (B)(6), INDEX PROCEDURE PERFORMED ON (B)(6) 2024, REPORTEDLY HAD 'SUPERFICIAL WOUND INFECTION, WOUND DEHISCENCE". A SMALL AMOUNT OF SEROUS DRAINAGE FROM A TINY DISTAL WOUND DEHISCENCE. KEFLEX WAS ADMINISTERED TO THE PATIENT.
Patient problems: Wound Dehiscence
MAUDE report 18843971 ↗InjuryFeb 26, 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) WOULD BE UNDERGOING IMPLANT REMOVAL AT NORTON CHILDREN'S FOR POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 18776148 ↗MalfunctionJan 3, 2024Break; Break
ON 05-DEC-2023 APIFIX WAS NOTIFIED THAT PATIENT #748 (B)(6) WAS SEEN IN THE CLINIC ON (B)(6) 2023 AND X-RAYS SHOWED THAT THE APIFIX ROD WAS BROKEN. PATIENT EXPERIENCED AN ACUTE ONSET OF PAIN THE WEEK PRIOR TO BEING SEEN IN CLINIC. SURGEON PLANS TO DO A REVISION IN (B)(6) 2024 BY REPLACING TO A NEW ROD.
Patient problems: Pain
MAUDE report 18434763 ↗MalfunctionDec 25, 2023Unintended Movement; Unintended Movement
ON (B)(6) 2023 APIFIX WAS NOTIFIED THAT PATIENT #744 (B)(6) FELT SOME CLICKING IN HER BACK A COUPLE OF WEEKS AGO AND AN X-RAY SHOWS FAILURE OF THE DEVICE'S RATCHET MECHANISM. FAMILY IS DECIDING BETWEEN AN EXCHANGE OF THE DEVICE OR FUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18390423 ↗MalfunctionNov 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON 13-OCT-2023 APIFIX RECEIVED A FACEBOOK MESSAGE FROM A MOM WHOSE 'DAUGHTER HAD AN APIFIX ROD IMPLANTED (B)(6) AGO. (B)(6) AGO THE DOCTOR REMOVED IT BECAUSE IT WAS AT FULL EXTENSION; DOCTOR PLACED THE PATIENT IN A NIGHT TIME BRACE. AT THE PATIENT'S 6 WEEK F/U, IT WAS DISCOVERED THAT HER CONDITION WORSENED BY 20 DEGREES, REACHING 45 DEGREES, AND THE MOM IS CONCERNED THAT THE ROD WAS REMOVED PREMATURELY AND MIGHT NEED TO BE REINSERTED. MOM WAS SEEKING GUIDANCE OR ASSISTANCE FROM THE COMPANY REGARDING THIS ISSUE.
Patient problems: Discomfort
MAUDE report 18117012 ↗MalfunctionSep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023 APIFIX WAS NOTIFIED THAT PATIENT (B)(6) WAS BEING REVISED TO A FUSION. THE REPORTED STATED THAT THE SURGEON'S REASONING FOR THE CONVERSION IS "PROGRESSION OF THE THORACIC SCOLIOSIS. WE DID THE APIFIX PROCEDURE FOR THE PATIENT'S PRIMARY LUMBAR CURVE."
Patient problems: Physical Asymmetry
MAUDE report 17688454 ↗MalfunctionAug 31, 2023Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth
ON 02-AUG-2023, APIFIX WAS NOTIFIED THAT PATIENT (B)(6), INDEX PROCEDURE (B)(6) 2022, UNDERWENT REVISION SURGERY ON (B)(6) 2023 DUE TO A LOOSE SCREW AND [IMPLANT AT] MAX EXTENSION. DURING THE REVISION THE MID-C 115MM ROD WAS REPLACED WITH A MID-C 125MM. NO REPORT OF PATIENT HARM/COMPLICATIONS WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17659033 ↗MalfunctionJun 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2023 APIFIX WAS NOTIFED THAT PATIENT #686 (PAS #086-A048) UNDERWENT REVISION SURGERY ON (B)(6) 2023. THE REASON FOR PATIENT #686 REVISION WAS "115MM MID C MAX DISTRACTED, AND NEED TO BE REPLACED WITH A LONGER DEVICE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17215337 ↗MalfunctionJun 5, 2023Break; Break
ON 05-MAY-2023 APIFIX WAS NOTIFIED THAT PATIENT (B)(6) UNDERWENT REVISION SURGERY ON (B)(6) 2023 DUE TO IMPLANT BREAKAGE.
Patient problems: Failure of Implant
MAUDE report 17057325 ↗MalfunctionMay 24, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
DURING [POSNA] PEDIATRIC ORTHOPAEDIC SOCIETY OF NORTH AMERICA ANNUAL MEETING 2023, APIFIX WAS NOTIFIED THAT PATIENT (B)(6) HAD AN IMPLANT BREAKAGE AND IS SCHEDULED FOR A REVISION.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16991692 ↗MalfunctionJan 25, 2023Break; Break
ON (B)(6) 2022, APIFIX WAS NOTIFIED THAT PATIENT (B)(4) WAS THROWING A FOOTBALL FOUR WEEKS AGO WHEN SHE STARTED TO HAVE LOW BACK PAIN. IT WAS REPORTED THAT X-RAYS SHOWED THAT SHE FRACTURED HER APIFIX SCREW AT L4.
Patient problems: Pain
MAUDE report 16239019 ↗MalfunctionJan 16, 2023Break; Break
ON (B)(6) 2022 APIFIX CLINICAL TRIALS MANAGER WAS INFORMED THAT PATIENT (B)(6) WAS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 16173155 ↗MalfunctionDec 28, 2022Migration; Migration
ON 30-NOV-2022 APIFIX WAS NOTIFIED THAT PATIENT #(B)(6) HAD A REVISION SURGERY PERFORMED ON (B)(6) 2022 TO REMOVE THE MID-C FOLLOWING COMPLAINTS OF PAIN. ACCORDING TO THE REPORTER, X-RAYS WERE TAKEN WHICH SHOWED MIGRATION OF THE SECOND PROXIMAL SCREW.
Patient problems: Pain
MAUDE report 16058667 ↗MalfunctionNov 3, 2022Break; Break
PATIENT#: (B)(6) INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2021 ON (B)(6) 2022, APIFIX WAS NOTIFED THAT THE PATIENT WAS INVOLVED IN A HIGH SPEED (MVA) MOTOR VEHICLE ACCIDENT WITH THE AIRBAGS DEPLOYED A COUPLE DAYS PRIOR. THE PATIENT WAS REPORTED TO HAVE SLIGHT BACK PAIN, SO HE CAME IN FOR IMAGES IN WHICH THE IMPLANT BREAKAGE WAS IDENTIFIED. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE MVA.
Patient problems: Failure of Implant
MAUDE report 15722092 ↗MalfunctionSep 3, 2022Migration; Migration
PATIENT #(B)(6) INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2022. AT THE PATIENT'S ONE MONTH FOLLOW UP, IT WAS IDENTIFIED THAT THE SCREW AT L4 HAD MIGRATED INTO THE CANAL. ON (B)(6) 2022 THE PATIENT WAS REVISED TO APIFIX PLACING A NEW SCREW AT L3. NO SEQUELAE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15353507 ↗InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem
APIFIX NOTIFY ON "CURVE PROGRESSION IN THIS PATIENT AND NOT UNDERSTANDING THE ROOT CAUSE."
Patient problems: Insufficient Information
MAUDE report 14336337 ↗
Other Posterior Ratcheting Rod System devices
- Minimally Invasive Deformity Correction (MID-C) System MID-C 125Apifix Ltd · Posterior Ratcheting Rod System53 reports
- Minimally Invasive Deformity Correction (MID-C) System MID-C 105Apifix Ltd · Posterior Ratcheting Rod System12 reports
- Minimally Invasive Deformity Correction (MID-C) System MID-C 95Apifix Ltd · Posterior Ratcheting Rod System1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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