MAUDE Adverse Event Report: APIFIX LTD PEDICLE SCREW, DIA:4.5 MM L:35 MM; POSTERIOR RATCHETING ROD SYSTEM,

Model Number STANDARD PEDICLE SCREW 4.5X35

Device Problem Fracture (1260)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

A review of dhr has demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.The risk of broken screw has been quantified at the time of this event and incident rate of 5.66% found to be well within the rate reported in the literature ( 0.2%-15.5%) ( cer dms-727 rev r).Regardless, apifix identified that 4.5 mm screws may not be strong enough in some cases and stopped using them in 2018.To date, 356 patients were implanted with a bigger screw size, or an extender that is being supported by two screws, and no upper screw breakage reports were noted (0%).

Event Description

The surgeon informed the company that the patient presented a sudden breakage of the cranial screw indicated in the x-ray.The patient complained on pain and weakness.

• Brand Name: PEDICLE SCREW, DIA:4.5 MM L:35 MM
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM,
• Manufacturer (Section D): APIFIX LTD; 17 tehelet street; misgav business park; misgav, 20174 00; IS 2017400
• Manufacturer (Section G): APIFIX LTD; 17 tehelet street; misgav business park; misgav, 20174 00; IS 2017400
• Manufacturer Contact: adi prager ; 17 tehelet street; misgav business park; misgav, 20174-00 ; IS 2017400
• MDR Report Key: 10325745
• MDR Text Key: 200403602
• Report Number: 3013461531-2020-00006
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993303
• UDI-Public: 7290014993303
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/22/2020

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
• Device Expiration Date: 04/20/2022
• Device Model Number: STANDARD PEDICLE SCREW 4.5X35
• Device Catalogue Number: AF4535
• Device Lot Number: AF 09-02-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2017
• 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