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

Model Number MID-C 125

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.The ct scan demonstrated that the screw slightly migrated into the spinal canal.Hospital lab tests verified late infection around the screw.The infection was the cause of the screw migration.Infection is not a device-related but procedure/patient-related problem.On (b)(6) 2020 the implant was removed, the patient is feeling ok, the left scapula pain is reduced.No change in patient posture.Late-onset infection is a known risk which was assessed and recorded by the product risk assessment dms-777 rev q hazard id 21.5 this complaint does not change the occurrences rate.This risk mitigated and controlled by: recommended surgeons to apply vancomycin powder intraoperatively ( according to dms-6009).Late infection literature summary dms- 6394 demonstrated a large variation in the reported late infection rate reaching up to 12.5% in ais population, the rate of late infection at the time of this event ((b)(6) 2020 ) when using the apifix system is 4.87% which is well within the rate reported in the literature.

Event Description

On (b)(6), the doctor reported that the patient complained of back pain, located near the left scapula.With time, the pain migrated and was located above the upper screw.The patient did not react to anti-inflammatory agents either antibiotic, and her blood tests did not show any signed inflammation, crp was negative.Ct scan indicated that the screw slightly migrated into the spinal canal, and the surgeon decided to remove the implant.Removal surgery was performed on (b)(6) 2020.

• 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: 10818264
• MDR Text Key: 215582808
• Report Number: 3013461531-2020-00010
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993068
• UDI-Public: 7290014993068
• Combination Product (y/n): N
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Expiration Date: 10/24/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 10-01-17
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2017
• 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