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

Model Number MID-C 125

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 05/23/2023

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: patient (b)(6) index procedure was performed on (b)(6)2020. patient age 10.5 at index surgery, eos case, within the indications for eos on (b)(6)2023 apifix received notification of an upcoming planned revision for the eos case.Surgery scheduled for thursday, (b)(6)2023.On (b)(6)2023 apifix received new information that the case has been brought forward due to an implant breakage. the surgeon and patient's parents and working towards ther date of (b)(6)2023 to perform the revision.Early images were provided.On (b)(6)2023 apifix was notified that patient (b)(6) underwent the revision surgery as planned.No report of patient harm or complications was received.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 for breakage due to the above increases when the implant reaches its maximal elongation.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of broken rod has been assessed and found to be acceptable the current 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 cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.Upon return of the implant, a failure analysis will be conducted.When further relevant information is identified with which to determine a cause, the complaint file will be updated and a supplemental medwatch will be filed.

Event Description

On (b)(6)2023 apifix received notification of an upcoming planned revision for an eos case.Surgery scheduled for (b)(6)2023.On (b)(6)2023 apifix received new information that the case has been brought forward due to an implant breakage.The surgeon and patient's parents working towards the date of (b)(6)2023 to perform the revision.Early images were provided.

Manufacturer Narrative

Return analysis: the explanted device was returned to orthopediatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.Minimal wear was observed on the spherical rings.Deformation was observed  on the spherical housing of the pole and a corresponding location on the extender.It is suspected that the kyphosis lead to repeated impact loading on the device which eventually lead to fracture.There were no obvious manufacturing or design defects which contributed to the failure.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 17169156
• MDR Text Key: 317540772
• Report Number: 3013461531-2023-00021
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/16/2023

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 Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-07-036-20
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 07/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Male