MAUDE Adverse Event Report: APIFIX LTD. MID-C 105; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 105

Device Problem Failure to Align (2522)

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

Event Date 09/13/2022

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 #(b)(6) index procedure was performed on (b)(6) 2022.On (b)(6) 2022, apifix was notified that patient #(b)(6) underwent a revision surgery the week prior (07-sep-2022) due to "increased kite angle resulting in the implant moving laterally and becoming fully extended." during the revision surgery, the original 105 mm device was replaced by a 115 mm device, the apifix screw was replaced with a larger diameter (mm) screw.And the extender was re-used.According to the surgeon, "the device expanded to the max, and this together with a bit too positive kite angle makes negative stress and risk of device failure.The decision was made to replace with a bigger implant and now there is more space for the mechanism, and also a much better kite angle.Correction is good." reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of 'extender angle progression' has been assessed and found to be acceptable.The company's incident rate of extender angle progression is 0.2% the risk of "extender angle increase" has been assessed and found to be acceptable.The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.A review of available patient x-rays identified that at immediate post-op, the extender angle was at 10; however, at 3 months post-surgery progression in the extender kite angle was noticed a clinical review of the available information (inter op, immediate post-op, 3 months post op xrays) suggested that it was likely that one of the following scenarios occurred which resulted in the angle progression: 1.The distal extender screw was not optimally placed or was not sufficient in size in the pedicle and hence affecting the screw purchase in the pedicle.2.Screw was not properly torqued during the index procedure.Should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.

Event Description

Patient #(b)(6) index procedure was performed on (b)(6) 2022.On (b)(6) 2022, apifix was notified that patient #(b)(6) underwent a revision surgery the week prior (07-sep-2022) due to "increased kite angle resulting in the implant moving laterally and becoming fully extended.".

• Brand Name: MID-C 105
• 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: 15586161
• MDR Text Key: 307072899
• Report Number: 3013461531-2022-00075
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 105
• Device Catalogue Number: AFS-105-040
• Device Lot Number: AF-10-01-19
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/12/2022
• Date Device Manufactured: 11/14/2019
• 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 Age: 18 YR
• Patient Sex: Female