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 Off-Label Use (1494)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/11/2020

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 pre-op x-rays demonstrates that the patient has a double curve (lenke 2) with lateral bending of 50°, while the mid-c system is indicated for patients: ·having adolescent idiopathic scoliosis (ais) classified as lenke type 1 or lenke type 5 having cobb angle up to 60 degrees only single curves (lenke 1 or 5) ·spinal deformity is flexible.Wrong patient selection is due to a surgeon use error.

Event Description

On (b)(6) 2020, the surgeon reported by e-mail that the patient has insufficient curve correction in addition to trunk imbalance.

• 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: 10216670
• MDR Text Key: 197338174
• Report Number: 3013461531-2020-00002
• Device Sequence Number: 1
• Product Code: QGP
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/25/2022
• Device Model Number: MID-C 105 MM WITH EXTENSION OF 40 MM
• Device Catalogue Number: AF105L
• Device Lot Number: AF 09-01-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR