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

Model Number MID-C 125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

First investigation: production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.User (surgeon and patient) information analysis: the patient was implanted with a standard pedicle screw.The screw has a counter torque feature (screw post), which protrudes over the m6 thread which may be the source of pain has been reported in some patients.Regarding the loss of lordosis of this patient, apifix cto evaluated and determine that the loss of lordosis is very minimal and the sva improved.Implantation of the system in l4 is associated with some loss of lordosis but not in the range reaching clinical significance.Corrective action: the design of the pedicel screw was improved to have low profile (lp) pedicle screws to better fit small/thin patients at risk for potential skin irritation due to the counter torque feature (screw post), which protrudes over the m6 thread in the standard screws.The lp pedicle screw counter-torque feature is now contained internally in the pedicle screw instead of protruding above the nut, an internal female torx connection is being used inside the threaded portion of the screw, allowing the height of the screw to be reduced, resulting in a lower profile.The lp screws are more compatible with thin patients.Risk assessment: pain associated with scoliosis is well described in the literature regardless of having corrective surgery.Pain can also be a transient complaint associated with the surgical procedure or be secondary to device failure, infection/inflammation, curve progression, screw pull-out, loosening, migration, protrusion and prominence.At the time of this report, we don't have a definite cause for the patient complaint of pain.At the time of this report (oct 04, 2021), the company's incident rate of pain is (b)(4) which is well within the rate reported in the literature ( cer -clinical evaluation report dms-727 rev t.(b)(4) ) the risk of pain is a known risk that has been assessed and found to be acceptable (dms#777 rev q1).Event of pain addressed in the ifu warnings and precautions section: "metallic implants can loosen, fracture, corrode, migrate, or cause pain".

Event Description

The patient suffered from pain in the region of the lower apifix screw.In addition to the loss of lordosis for his lenke 5.

• 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: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 12688640
• MDR Text Key: 278124830
• Report Number: 3013461531-2021-00036
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 10-01-19
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/25/2021
• Date Device Manufactured: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention