MAUDE Adverse Event Report: APIFIX LTD. MID-C 105; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 105

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, apifix was notified that patient (b)(6), whose index procedure was performed on (b)(6) 2019, reports hearing a metallic sound when she bends. no report of patient complications were received.

Manufacturer Narrative

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.Apifix was provided with two xray images (one from (b)(6) 2019 and the other from (b)(6) 2022).Apifix requested additional images, specifically lateral images (if available) and any other x-rays between (b)(6) 2019 and (b)(6) 2022.No additional images have been provided.Apifix was made aware that the patient's family will visit with the surgeon in september 2022 where the surgeon will discuss the option of either converting to fusion or replace the apifix device.Apifix has been unable to obtain additional information regarding the circumstances surrounding this event; a cause for the reported failure could not be established.Should new information become available, a supplemental mdr will be submitted.

Manufacturer Narrative

On 20-dec-2022 apifix was notified that the patient was revised to a new implant on (b)(6)2022.No report of patient harm or complications was received. the noise allegedly originated from breakage of the device at rod's end-of-way.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.As part of apifix commitment to continuous improvement, capa #020-01 was initiated to further investigate to prevent and minimize the rate of implant breakage.The company investigation indicated that implant breakage can result from trauma, practicing severe sports, development of hyper-kyphosis, inserting the pedicle screws in a wrong trajectory, not working according to the surgical technique, and most commonly from the implant reaching its end of the way.Breakages were evident in 3 main regions, the implant base, the main rod, and the rod's connection to the poly-axial joint.The most common point of failure was the implant rod in implants reaching their maximal elongation.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.

• Brand Name: MID-C 105
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 15137331
• MDR Text Key: 304184112
• Report Number: 3013461531-2022-00033
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: 170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

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 105
• Device Catalogue Number: AFS-105-040
• Device Lot Number: AF-11-04-17
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 12/29/2022
• Date Device Manufactured: 11/29/2017
• 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: 15 YR