MAUDE Adverse Event Report: APIFIX LTD; POSTERIOR RATCHETING ROD SYSTEM,

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Implant Pain (4561)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: patient information: the x-ray demonstrates that the screw used in this case was a standart screw and not the current lp version.Previous complaints of screw protrusion were reported to the company ((b)(4)), all when using the standard screw in very thin patients.Based on x-ray evaluation, we assume that in this case the patient was thin as well, and therefore the distance between the pedicel screw tip and the back skin was small, which may lead to contact and skin irritation.Design: the standard pedicle screw that was used in this case has a counter torque feature which is protruding over the m6 thread.This design was used in hundreds of patients with no problem, but can irritate the skin of very thin patients.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 is more compatible with thin patients.Risk assessment: screw irritation is a known risk that was assessed and recorded by the product risk assessment dms777 rev q hazard id 1.34 this complaint does not change the occurrences rate.The rate of screw protrusion is 1.87% when standard screws are used and 0.46% when lp screws are used (after mitigation implementation).The rate is well within the literature (0.3%-9%, cer 727 rev t).The company is continuing to monitor skin irritation complaints.

Event Description

The patient had a removal surgery on (b)(6) 2021 due to screw protrusion and the patient complaining about pain.

• 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: 12201733
• MDR Text Key: 262614305
• Report Number: 3013461531-2021-00026
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 07/20/2021

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
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/21/2021
• 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 Outcome(s): Required Intervention