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

Model Number MID-C 125

Device Problem Break (1069)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, apifix identified that the mother of an apifix patient posted in a facebook page (scoliosis - support and info) that one of the screws broke in her daughter's implant since the index procedure two and a half years prior.The mother was asking 'the forum' for recommendations on how to proceed.Apifix identified the patient as patient #402, index procedure performed on (b)(6) 2020.

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 #402 index procedure was performed on (b)(6) 2020.On (b)(6) 2022, apifix identified that the mother of apifix patient #402 posted in a facebook page (scoliosis - support and information) that one of the screws broke in her daughter's device since the index procedure two and a half years prior.The mother was asking for recommendations on how to proceed.The mother further noted that she has followed up with the surgeon who advised to continue observing if there is any change in the patient curve or any signs of pain, in which case the patient should return for revision surgery.Apifix has reached out to the surgeon for additional information, specifically patient x-rays.Apifix also asked to find out how the screw breakage was discovered.On (b)(6) 2022 the surgeon notified apifix that "the (screw breakage) finding was coincidental, and the patient was pain-free.The curve had only progressed a little"; x-rays were provided which show the apifix screw had broken.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of screw breakage has been assessed and found to be acceptable the current screw 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.Although no report of serious injury was received, this event may lead to a revision surgery, thus the complaint will be reported in an abundance of caution.If any further relevant information is identified, the complaint file will be updated and a supplemental medwatch will be filed.

• 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: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 16120250
• MDR Text Key: 308708971
• Report Number: 3013461531-2022-00070
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-10-01-19
• Date Manufacturer Received: 12/11/2022
• Date Device Manufactured: 11/13/2019
• 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 Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Female