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

Model Number MID-C 125

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

First investigation: user (surgeon and patient) information analysis: the patient was treated out of the device indications for use as the patient size of the major curve was over 60°.The surgery was performed in a minimal invasive approach (mis), which makes it quite challenging to verify that the surface below the implant is sufficiently clean from any soft or hard tissue before placing the implant.For this reason, the use of mis technique is not recommended by the company and the surgical technique instructs to perform the surgery with an open midline incision.The patient is a competitive swimmer and continued it for two years post-surgery.Material and manufacturing: the production process and material data were reviewed and found acceptance and compliance with the product specification.Conclusion: misuse: insufficient tissue removal below the implant may be the cause of the device breakage - it is challenging to verify that the surface below the implant is sufficiently clear from access tissue when operating in an mis approach.At the location of the fracture pressure from the transverse process or any other hard tissue, below the implant may lead to rod breakage.For this reason, the use of the mis technique is not recommended by the company and the surgical technique instructs to perform the surgery with a vertical midline incision.Although the patient pre-operative kyphosis was below 55, the implant could not accommodate the kyphosis angle developed over time.The patient practice in competitive sports might have also been a contributing cause in the device breakage.Rom early 2019 the company is not recommending the use of 2 extenders, nevertheless, this does not seem to play a part in the subsequent breakage of the device.Corrective action: the company already implemented corrective action with the following: the use of the mis technique is not recommended by the company and the surgical technique instructs to perform the surgery with a vertical midline incision.The company is in the process of implementing an extender bender surgical instrument (eco 8729), which is a tool that will allow the surgeon to bend the extender to better accommodate the patient's kyphosis.Risk assessment: the device breakage current rate is (b)(4) which is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (0.2%-15.5%) (cer dms-(b)(4) rev t).The risk of the broken rod has been assessed and found to be acceptable (dms# (b)(4) rev q1 hazard id 1.8 and id 1.7).

Event Description

On (b)(6) 2021, the surgeon reported by e-mail that follows up x-ray demonstrated the breakage of the implant.

• 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 street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 11870728
• MDR Text Key: 252906696
• Report Number: 3013461531-2021-00022
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/22/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 11-05-17
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/24/2021
• Date Device Manufactured: 11/22/2017
• 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 Outcome(s): Required Intervention