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

Model Number MID-C LP 125

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 08/24/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 apifix was notified that patient #575 is scheduled for revision surgery on (b)(6) 2023 due to 'hardware breakage'.

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 (b)(6) 2023 apifix was notified that patient #(b)(6) is scheduled for revision surgery due to 'hardware breakage'.  additional information received on (b)(6) 2023 reported that the patient's revision occurred on 28-aug-2023.According to the reporter, the patient was on vacation with her parents and reported occurrence of pain.No trauma was reported.X-ray was provided which shows the implant breakage at the base.Risk assessment: 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).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 - [implant breakage] has been assessed and found to be acceptable.The 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 clinical evaluation report.The explanted device is expected to be returned to the manufacturer for analysis.Upon completion of the evaluations, if new pertinent information comes to light, then a supplemental medwatch report will be submitted.

Manufacturer Narrative

Return analysis: the explanted device was returned to orthopediatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.The device was fractured around the mid-point of the rod.Fracture origin is uncertain but believed to in the corner of the device shown circled in image 3.The mode of fracture is believed to be fatique as indicated by a uniform fracture surface.The rest of the device appeared to be functioning properly.The spherical rings showed no observable signs of wear.

• Brand Name: MID-C LP 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 17763383
• MDR Text Key: 323576840
• Report Number: 3013461531-2023-00043
• 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,Followup
• Report Date: 12/24/2023

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 Operator: Health Professional
• Device Model Number: MID-C LP 125
• Device Catalogue Number: AFL-125-050
• Device Lot Number: AF-05-018-20
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 12/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• 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: 13 YR
• Patient Sex: Female