MAUDE Adverse Event Report: APIFIX LTD. MID-C 115; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 115

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 12/19/2022

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) 2022 apifix clinical trials manager was informed that patient (b)(6), index procedure performed on (b)(6) 2020, is scheduled for revision surgery on (b)(6) 2022 due to implant breakage at end-of-way.Clinical affairs reviewed the patient's pre-op plan and x-rays.Per apifix measurements, the patient's (pre-op) lateral bending (lb) was measured at 27° each curve, which constitutes 2 (two) structural curves (out of indication).Per the pssg (pediatric spine study group) measurements, patient x-rays revealed that the patient's primay cobb angle to be at 61° (out of indication).Apifix advised placement of the implant to be at t9-t10, however the surgeon placed the device at t8-t9.On (b)(6) 2022 the patient underwent a revision procedure in which "the initial implant was removed and new apifix implant reimplanted.The t8 and l3 screws remained intact.The t9 was removed and replaced with a new larger screw." 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.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 will be filed.

Event Description

On (b)(6) 2022 apifix clinical trials manager was informed that patient (b)(6) was scheduled for revision surgery on (b)(6) 2022.

Manufacturer Narrative

Return analysis: upon receiving the explanted devices at orthopediatrics in warsaw, in, the devices were cleaned and sterilized.The devices were photographed and analyzed.The device was fractured at the mid-point of the pole.Post fracture it seems the pole remained within the body of the mid-c as indicated by wear and material deformation at the edges of the pole fracture plane and along the inner diameter of the female body.Spherical rings did show any obvious signs of wear.

• Brand Name: MID-C 115
• 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: 16173155
• MDR Text Key: 307782608
• Report Number: 3013461531-2022-00072
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-01-01-19
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• 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: 18 YR
• Patient Sex: Male