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

Model Number MID-C 125

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

On 28-dec-2022 apifix was notified that patient#: (b)(6), index procedure performed on (b)(6)2022, has a broken implant.

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: on 28-dec-2022 apifix was notified that patient#: (b)(6), index procedure performed on (b)(6)2022, has a broken implant.The doctor's plan is to revise the patient on (b)(6) 2023.Apifix clinical affairs requested pre-op x-rays from the surgeon, which were provided; apifix measured the kyphosis between t12 and t5 which was 35°, just on the boundary of the implant limilation regarding kyphosis adaptation, however in this case the surgeon used a lenke 5 extender (the patient case is lenke 5).Due to (lenke 5) extender being straight rather than pre-bent, the extender can only cover 20°.The breakage occurred at the extender conjunction (t9-t10), at the peak of the kyphosis.Had a prebent extender been used, it may have prevented the implant breakage.Implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis, inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).The risk for breakage due to the above increases when the implant reaches its maximal elongation.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of broken rod has been assessed and found to be acceptable the current implant 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.Apifix reached out to the surgeon prior to this revision to remind him that the bent extender might have prevented the implant breakage & he should be using the pre-bent extender (specifically a lenke 1 - left) in this revision.The revision surgery was performed on (b)(6) 2023, during which the mid-c was replaced with the same size and a lenke 1-left extender was used.

• 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: 16239018
• MDR Text Key: 309154606
• Report Number: 3013461351-2022-00077
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• 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-03-079-21
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Date Device Manufactured: 08/18/2021
• 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: 17 YR
• Patient Sex: Female