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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

According to the patient picture, there is bursitis in the area of the upper screw.Most probably due to irritation of the skin by this version of the screw (before the new design of lp screws were introduced to the market).The current complaint uses standard screws that are a previous design with a counter-torque feature (screw post) which protrudes over the thread in the standard screws.Since the patient and the device data is not yet available for evaluation full investigation and conclusion cannot be determined at this stage.Corrective action: the company already implemented corrective action of low profile screws (lp) per eco -031 allowing better compatibility with the patient body.The lp pedicle screw is identical to the standard apifix pedicle screw except that the counter-torque feature is contained internally in the post instead of protruding above the nut.Risk assessment: currently, the company does not have sufficient information to conclude that the present case is a result of prominent hardware.Still, the risk of prominent hardware has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.34) at the time of this report (dec 16, 2020), the company's incident rate of prominent hardware is 0.77% and 0 %following mitigation of new low profile( lp) screw.

Event Description

The surgeon reported that the patient will have revision surgery due to bursitis.

• Brand Name: POSTERIOR RATCHETING ROD SYSTEM,,,
• Type of Device: MID-C
• 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: 11105567
• MDR Text Key: 224734156
• Report Number: 3013461531-2020-00022
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention