MAUDE Adverse Event Report: APIFIX LTD. MID-C 115; POSTERIOR RATCHETING ROD SYSTEM

Model Number	MID-C 115
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 apifix was notifed that patient #686 (pas #086-a048) underwent revision surgery on (b)(6) 2023.The reason for patient #686 revision was "115mm mid c max distracted, and need to be replaced with a longer device".
Additional 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 #686 (pas study #086-a048) index procedure was performed on (b)(6) 2021 on (b)(6) 2023 apifix was notifed that patient #686 (pas #086-a048) underwent revision surgery on (b)(6) 2023.The reason for patient #686 revision was "115mm mid c max distracted, and need to be replaced with a longer device".Reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev r this complaint does not change the occurrences rate.The risk of mechanical failure of the mid-c mechanism resulting in patient re operation due to inadequate curve correction is a known risk, and has been characterized and documented as acceptable within full risk assessment.The explanted device has been returned to the manufacturer and will be evaluated.Following the evaluation, if new pertinent information comes to light, then a supplemental medwatch report will be submitted.*medical device problem code used was: 3191 - appropriate term/code not available.The mid-c system is a ratchet-based self-expandable rod designed to passively increase its length and subsequently maintain its length as the child bends in the corrective direction and also accommodate the natural growth of the spine of young children.In this case the implant (rod) was at its maximum elongation.The appropriate code which isn't available is 'device at maximum elongation'.

• Brand Name: MID-C 115
• Common Device Name: 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: 17215337
• Report Number: 3013461531-2023-00024
• Device Sequence Number: 6232286
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-11-046-20
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/28/2023
• Date Device Manufactured: 04/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR
• Patient Sex: Female