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

Model Number MID-C 115

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Discomfort (2330)

Event Date 10/13/2023

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.On 13-oct-2023 apifix received a facebook message from a mom whose daughter had an apifix rod implanted (b)(6) ago.According to the mom, (b)(6) ago the doctor removed it because it was at full extension; doctor placed the patient in a night time brace. at the patient's 6 week f/u, it was discovered that her condition worsened by 20 degrees, reaching 45 degrees, and the mom is concerned that the rod was removed prematurely and might need to be reinserted.Mom is seeking guidance or assistance from the company regarding this issue.Apifix spoke with the mother identified the patient as patient #:(b)(6), index procedure performed on (b)(6) 2022. on (b)(6) 2023 the implant was removed.  according to the mom, the doctor said the device needed to be removed because of full extension and the patient's spine would grow curved for the remainder of her growth years and would lose correction.According to the mother, at the patient's 6 week follow up she (patient)  had lost 20° of correction and is back at 45°, and now the doctor wants the patient in a day & night brace.Apifix reached out to the surgeon for additional information which was received. the surgeon stated that the patient complained of discomfort, thereby leading him to explant the device.The surgeon further put the patient back in an external brace, which may have contributed to his "wait and watch" decision. no additional information was received.Re-operation events are a known risk that was assessed and recorded by the product risk assessment.The risk of mechanical failure of the mid-c mechanism resulting in patient re-operation due to inadequate curve correction is a known risk, and has been characterized and documented as acceptable within full risk assessment. the events of 'implant failure to maintain extension/curve correction' and 'subsequent surgical interventions are addressed in the ifu as potential risks associated with the mid-c system.Apifix is closing this complaint at this time, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If new relevant information is made available, apifix will re-open and update the complaint record and file a follow up medwatch report.*medical device problem code used was: 3191 - appropriate term/code not available.The mid-c system is a ratchet-based self-expandable rod designed to passively increase its length and subsequently maintain its length as the child bends in the corrective direction and also accommodate the natural growth of the spine of young children.In this case the implant (rod) was at its maximum elongation.The appropriate code which isn't available is 'device at maximum elongation'.

Event Description

On 13-oct-2023 apifix received a facebook message from a mom whose 'daughter had an apifix rod implanted (b)(6) ago.(b)(6) ago the doctor removed it because it was at full extension; doctor placed the patient in a night time brace.At the patient's 6 week f/u, it was discovered that her condition worsened by 20 degrees, reaching 45 degrees, and the mom is concerned that the rod was removed prematurely and might need to be reinserted.Mom was seeking guidance or assistance from the company regarding this issue.

• 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: 18117012
• MDR Text Key: 328445869
• Report Number: 3013461531-2023-00055
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• 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: MUS-115-040
• Device Lot Number: AF-07-037-20
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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 Age: 11 YR
• Patient Sex: Female