• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APIFIX LTD. MID-C 125; POSTERIOR RATCHETING ROD SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APIFIX LTD. MID-C 125; POSTERIOR RATCHETING ROD SYSTEM Back to Search Results
Model Number MID-C 125
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Manufacturer Narrative
Production process analysis: a review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.User (surgeon and patient) information analysis: on (b)(6) 2024 apifix was notified that patient #566 has a broken implant.It was further reported that the curve which was 46° before the surgery is now 40°, with the rib hump itself having a clinical atr (axial trunk rotation) of 20°.This patient is fully grown and since there is no pain or concern for curve progression (for now), the surgeon and patient have decided to monitor for now.There is no plan for a revision at this point.Risk assessment: implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis, inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).The risk of mechanical failure of the mid-c mechanism: [implant breakage] has been assessed and found to be acceptable.The implant breakage rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report.Apifix is closing this complaint but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.
 
Event Description
On (b)(6) 2024 apifix was notified that patient #566 has a broken implant.It was further reported that the curve which was 46° before the surgery is now 40°, with the rib hump itself having a clinical atr (axial trunk rotation) of 20°.This patient is fully grown and since there is no pain or concern for curve progression (for now), the surgeon and patient have decided to monitor for now.There is no plan for a revision at this point.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MID-C 125
Type of Device
POSTERIOR RATCHETING ROD SYSTEM
Manufacturer (Section D)
APIFIX LTD.
1 hacarmel st.
yokneam ellit, 20692 07
IS  2069207
Manufacturer (Section G)
APIFIX LTD.
1 hacarmel st.
yokneam ellit, 20692 07
IS   2069207
Manufacturer Contact
alan vaisman
1 hacarmel st.
yokneam ellit, 20692-07
IS   2069207
MDR Report Key18919094
MDR Text Key337856215
Report Number3013461531-2024-00014
Device Sequence Number1
Product Code QGP
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
H170001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 03/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMID-C 125
Device Catalogue NumberAFS-125-050
Device Lot NumberAF-07-036-20
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2024
Initial Date FDA Received03/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age17 YR
Patient SexFemale
-
-