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

Model Number MID-C 125

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.Patient#: (b)(6) index surgery was performed on (b)(6) 2022.Patient x-rays taken in on (b)(6) 2022 showed that the t5 polyaxial screw had begun to migrate (pull-out) resulting in an exaggerated kite angle.Although no revision date had been set as of yet, the family is against a fusion at all costs even with a stiff curve that won't bend out much under 30 degrees.Apifix clinical affairs reviewed all the available information and noted: the surgery plan stated: "while the case does ultimately meet all of the fda criteria summarized above, the patient is at the high end of all objective measures: 60-degree primary curve, only bends to 27 degrees, significant wedging of vertebrae around the apex, etc.However, patient is risser 0 and may do well with ideal screw placement and maximal intraoperative correction." - measurements and comments from geoff haft, md review of the patient's inter-op x-rays demonstrated that the extender wasn't positioned per the company's surgical technique (the patient extender angle was measured at 22°; the surgical technique states that the extender angle should be 5-15° compared to the mid-c rod).The extender misalignment eventually lead to the screw pulling out as the extender angle continued to progress.The company's incident rate of extender misalignment is (b)(4).The risk of "extender and mid-c system not properly aligned" has been assessed and found to be acceptable.

Event Description

Patient#: (b)(6) index surgery was performed on (b)(6) 2022.On (b)(6) 2022, it was reported that the t5 polyaxial screw had begun to migrate (pull-out) resulting in an exaggerated kite angle.  no revision date had been set as of yet.

Manufacturer Narrative

On 17-nov-2022 apifix was notified of the patient's device removal performed on (b)(6) 2022.Per the reporter, the case went well.Both top screws appeared to have pulled out (x-rays were provided).  the implants are expected to be returned to apifix for evaluation.Should additional information be made available, apifix will file a follow up mdr.

• 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: 15481746
• MDR Text Key: 306260914
• Report Number: 3013461531-2022-00047
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

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: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2022
• Initial Date FDA Received: 09/25/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 11/21/2022
• Date Device Manufactured: 05/20/2020
• 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 Age: 11 YR
• Patient Sex: Female