MAUDE Adverse Event Report: APIFIX LTD. MID-C 95; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 95

Device Problem Off-Label Use (1494)

Patient Problem Failure of Implant (1924)

Event Date 06/21/2022

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: patient#: (b)(6) index surgery was performed on (b)(6) 2021.On (b)(6) 2022, apifix was made aware that the patient was revised to fusion.On (b)(6) 2022 additional information was provided that "the patient (b)(6) had re-op secondary to maxing out her implant and having an increased curvature of the spine.No reported complaints of pain.The patient actually wanted to exchange for another apifix but the father wanted to proceed with a definitive spinal fusion." despite multiple attempts to obtain additional information, specifically x-rays (post-op xrays from after the index procedure and any xrays prior to revision), no additional information was provided.A review of the patient's preop plan identified that this patient appeared to be more of a lenke 3 than a lenke 1 or lenke 5; thus a borderline case with a low chance of being successful solely with an apifix treatment.This patient was treated out of indication.(the mid-c system is indicated for use in patients with adolescent idiopathic scoliosis (ais) having a single curve and classified as lenke 1 (thoracic major curve) or lenke 5 (thoracolumbar/lumbar major curve)) reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of curve progression has been assessed and found to be acceptable.The current rate for all relevant criteria (curve progression, insufficient curve correction, imbalance) 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 '.

Event Description

Patient #: (b)(6).Index surgery was performed on (b)(6) 2021.On (b)(6) 2022, apifix was made aware that the patient was revised to fusion.

• Brand Name: MID-C 95
• 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: 15076404
• MDR Text Key: 304793811
• Report Number: 3013461531-2022-00027
• Device Sequence Number: 1
• Product Code: QGP
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID-C 95
• Device Catalogue Number: MUS-095-030
• Device Lot Number: AF-02-002-20
• Date Manufacturer Received: 06/24/2022
• Date Device Manufactured: 03/11/2020
• 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: 15 YR
• Patient Sex: Female