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

Model Number MID-C 115

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

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.Patient #582 index procedure was performed on (b)(6) 2021 on (b)(6) 2023, the surgeon notified apifix that patient #582 is undergoing a revision on saturday ((b)(6) 2023) due to the device having reached its maximum length and the patient is still growing.Patient has a 115mm apifix and surgeon will replace it with a 125mm.If needed, he would change the upper screws to one level below (preferred over changing the lower screw to one level above).On (b)(6) 2023 the surgeon notified apifix that during the revision, the implant was replaced with an apifix 125mm (which, according to the surgeon, has 13mm left to legthen).Since the patient is a risser 3/4 and they parents aren't very tall, the surgeon hopes it is enough.The surgeon further added that "in the end, the surgery was simple.The final postoperative cobb angle is 25º." reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev r this complaint does not change the occurrences rate.The risk of misuse (using the device outside the approved indications) resulting in patient reoperation due to inadequate curve correction (or decreased outcome from therapeutic treatment) is an known risk, and has been characterized and documented as acceptable within full risk assessment.The apifix mid-c system is indicated for use in patients with adolescent idiopathic scoliosis (ais) for treatment of single curves classified as lenke 1 (thoracic major curve) or lenke 5 (thoracolumbar/lumbar major curve), having a cobb angle of 35 to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs, and thoracic kyphosis less than 55 degrees as measured from t5 to t12.(dms-766 rev w1- mid-c system instructions for use).The patient had a 60 degree curve with a measurement of 50° on lateral side-bending radiographs.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.

Event Description

On (b)(6) 2023 a surgeon from spain notified apifix that patient #582 is undergoing a "planned" revision on saturday ((b)(6) 2023) due to the device having reached its maximum length and the patient is still growing.Patient has a 115mm apifix and surgeon will replace it with a 125mm.

• 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 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: 16929117
• MDR Text Key: 315179662
• Report Number: 3013461531-2023-00014
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID-C 115
• Device Catalogue Number: AFS-115-040
• Device Lot Number: AF-07-038-20
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Date Device Manufactured: 08/18/2020
• 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 Outcome(s): Other
• Patient Sex: Male