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

Model Number	MID-C 115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Production process analysis: 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.User (surgeon and patient) information analysis: patient (b)(6) index procedure was performed on (b)(6) 2021.Patient (b)(6) underwent revision surgery on (b)(6) 2022 due to the implant having reached maximum extension and (secondary) curve progression.Patient was doing well post initial implant and had been completely asymptomatic from a pain standpoint.The discovery was made for needing a revision when they presented to the clinic and was noted to have some increased deformity of the left primary lumbar curve.A new and larger sized apifix implant was placed in the patient to better correct their adolescent idiopathic scoliosis.On (b)(6) 2023 apifix was notified that patient (b)(6) was being revised to a fusion.The reporter stated that the surgeon's reasoning for the conversion is "progression of the thoracic scoliosis.We did the apifix procedure for the patient's primary lumbar curve." reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of curve progression has been assessed and found to be acceptable.The current rate for all relevant criteria (curve progression, insufficient curve correction, imbalance) is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment the explanted device has been returned to the manufacturer and will be evaluated; upon its completion, once new information comes to light, then a supplemental medwatch report will be submitted.
Event or Problem Description
On (b)(6) 2023 apifix was notified that patient (b)(6) was being revised to a fusion.The reported stated that the surgeon's reasoning for the conversion is "progression of the thoracic scoliosis.We did the apifix procedure for the patient's primary lumbar curve.".
Additional Manufacturer Narrative
Device was returned to manufacturer for analysis.Engineering analysis: the explanted device was returned and was subjected to cleaning and steam sterilizing.The explant was evaluated by engineering and photographed.The device functioned normally.Slight material deformation was noted on one spherical ring housing, but not believed to be contributory to the device removal.The extender was removed and the spherical rings photographed.Minimal wear was observed on the spherical rings.The wear did not appear to breach the adlc coating layer.The wear analysis portion of retrieval and analysis protocol was not conducted because the time of implantation was less than 12 months.Observed on the spherical rings, one ring had minor scratches.The device was fractured at first tooth location, at the mid-point of the pole.The fracture plane was photographed.There were no obvious manufacturing or design defects which contributed to the failure.Curve progression can result from several reasons, such as device misplacement, operating on patients out of the approved indication, implant size selection, extender misalignment, screw misplacement /migration, screw pull-out, implant breakage, infection, ratchet malfunction, and in some cases for no apparent reason.The progression can be either or both of the primary or secondary curve and may also be reported together with pain and or spine imbalance.Cause for the secondary curve progression could not be determined.

• Brand Name: MID-C 115
• Common Device Name: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 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: 17688454
• Report Number: 3013461531-2023-00038
• Device Sequence Number: 15061587
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: 15 YR
• Patient Sex: Male