MAUDE Adverse Event Report: APIFIX LTD MID-C 105 MM WITH EXTENSION OF 40 MM; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 105 MM WITH EXTENSION OF 40 MM

Device Problem Use of Device Problem (1670)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/08/2020

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.A review of the patient's x-rays demonstrate that the problem seen at the 1 year follow-up is an outcome of placing the system in a wrong location, as it should have been placed 2 levels below its current location.The wrong placement is due to a surgeon use error.

Event Description

On (b)(6) 2020, the orthopedic surgeon reported by e-mail that the one year follow up x-ray indicated an increase in the lumbar curve (11º to 27º).The thoracic curve correction is maintained and did not progress.

• Brand Name: MID-C 105 MM WITH EXTENSION OF 40 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: 10204449
• MDR Text Key: 197095440
• Report Number: 3013461531-2020-00001
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/22/2022
• Device Model Number: MID-C 105 MM WITH EXTENSION OF 40 MM
• Device Catalogue Number: AF105L
• Device Lot Number: AF 11-05-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2017
• 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
• Patient Age: 15 YR