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

Model Number MID-C 115

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

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: apifix reached out to the pas (post approval) study coordinator who provided additional information on (b)(6)2023: "patient was seen in clinic on (b)(6)2023 (earlier than their originally scheduled 2 year f/u in late may) for increasing pain & hearing noises around the device.Patient reported 2 concussions with loss of consciousness (1 after fall while doing box jumps, and a second after being hit in the head with a hockey puck).Beginning of noisy symptoms did correlate to sometime after the fall from box jumps.No le numbness, tingling, weakness, or bowel/bladder dysfunction noted.Pi was unable to reproduce noise from the device during the appointment.Ap/lat spine films were taken which showed no change in the appearance of the post-operative spine and no evidence for spinal hardware failure or loosening.Per physician note: "recent increase in back pain, status post recent fall on the back with potential device fracture and mild progression of scoliosis curve.We reviewed exam, images, and treatment options today in office.We reviewed conservative and surgical treatment options.Like to continue with conservative treatment at this time and assess device and scoliosis alignment in roughly 2 months with upright ap/lateral scoliosis radiographs in regular xr machine, not in eos, to help us more definitively assess implant fracture."  the patient is scheduled to return for their 2 year visit on (b)(6)2023.Study coordinator reached out to physician and he said the information the sc had was the most up-to-date that he knew of.He is going to reach out to the reporter (index procedure surgeon) and let the study coordinator know if there is something different to report.Will let apifix know once he finds out.On (b)(6)2023 additional information was received from the reporter. the reporter (index procedure surgeon) reiterated that there was an implant breakage; the ratchet was fully extended before the time of breakage. patient presented with mechanical symptoms/sounds.The revision may have not yet been completed; the last the reporter heard was they were considering going to mayo in rochester. no additional information has been received.  implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis, inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).The risk for breakage due to the above increases when the implant reaches its maximal elongation.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of broken rod has been assessed and found to be acceptable the current implant breakage rate due to any reason 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.Apifix is continuing to investigate this event.When further relevant information is identified, the complaint file will be updated and a supplemental medwatch will be filed.

Event Description

During [posna] pediatric orthopaedic society of north america annual meeting 2023, apifix was notified that patient (b)(6) had an implant breakage and is scheduled for a revision.

Manufacturer Narrative

Additional information: on 26-jun-2023 apifix followed up with the patient's physician for additional information which was provided.According to the physician, "the patient did return.No obvious implant failure was identified and it was communicated to the family.Nothing concerning was seen and the report of the failure by the reporter (dr.(b)(6)) was a little premature.The patient still reports noises and creaks, but has been unable to produce them in office.Otherwise, the patient is doing fine.Her spine is stable.".Doctor and family agreed to continue monitoring the patient for another 6 months.The company's post market surveillance activities demonstrate that mid-c system mechanical noise is usually secondary to a malfunction of the device ratchet, breakage or components loosening, and rarely as a standalone complaint.In the present report, no obvious implant failure was identified and nothing concerning was seen.The patient still reports noises and creaks, but has been unable to produce them in office.Patient is doing fine.Her spine is stable.Doctor and family agreed to continue monitoring the patient for another 6 months.

• Brand Name: MID-C 115
• Type of Device: 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 st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 16991692
• MDR Text Key: 316479256
• Report Number: 3013461531-2023-00016
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 06/26/2023
• Date Device Manufactured: 01/23/2019
• 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 Sex: Female