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

Model Number MID-C 115

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Fistula (1862)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

First evaluation: production process: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Follow up information: the patient is skinny and sits several hours a day, leading to friction between her back against the back of the chair.The ct shows good fixation, lab test results are normal.The surgeon has not decided on the curse of action to treat this event, the company will continue to follow-up on the event.Following the report, the company asked the study coordinator to fill in a complication report in the pssg study registry.Currently the event root cause is classified as tissue irritation due to prominence of the hardware.Due to the risk of hardware prominence in skinny patients the company implanted eco 31 - low profile pedicle screws with shorter head to prevent irradiate skin of smaller and thinner patient.The rate of implant prominence prior to eco 31 is (b)(4) and (b)(4) post eco-31.

Event Description

The surgeon reported on (b)(6) 2021 that the patient feels local discomfort and has a bursa over the distal implant.

Manufacturer Narrative

Return analysis: upon receiving the explants at orthopediatrics they were cleaned, sterilized, and subjected to an engineering evaluation.Minor wear was observed on approximately <5% of one ring surface as indicated by a color difference on the surface of one of the spherical rings.The other ring showed no visible signs of wear.The rings rotated freely.No fracture or failure of the device was observed.The devices were taken to purdue university fort wayne for sem analysis.The area of noted wear was examined and spalling of the coating was observed.Spectrum 9 and 10 were on regions that were clearly undisturbed adlc coating.Spectrum 11 and 12 were on regions where it was clear that the adlc had been worn through.Spectrum 9 and 10 showed primarily carbon, as expected from the adlc coating.Spectrum 11 and 12 showed primarily chromium, which indicates that the secondary layer of the adlc coating, which is comprised of chromium and nickel, is not worn through to the base material of ti6al4v.No observations during the evaluation indicate that the removal of the device was related to the performance of the device.

• 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: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 11647615
• MDR Text Key: 260449347
• Report Number: 3013461531-2021-00016
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2023

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 Expiration Date: 01/10/2024
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF 01-01-19
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 05/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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