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

Model Number MID-C 125

Device Problems Overcorrection (3006); No Apparent Adverse Event (3189)

Patient Problems Physical Asymmetry (4573); Insufficient Information (4580)

Event Date 10/28/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.User (surgeon and patient) information analysis: the lordosis changed from 62 at pre-op to 54 at post-op which is reasonable.The curve lb bending was 33.The lower screw is suspected to be out of the pedicle, only a ct can confirm.Risk assessment: the current device screw misplacement /migration rate due to any reason is 1.62% and is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (b)(4).The risk of the screw misplacement /migration has been assessed and found to be acceptable (b)(4).

Event Description

The surgeon, askd apifix's opinion about the paitent flat back in the lumbar spine, and an overcorrection of the lumbar scoliosis.

Manufacturer Narrative

The risk of spine imbalance is a known risk.The current spine imbalance complaint rate is (b)(4) and has been assessed and found to be acceptable per the company cer.(dms-727 rev t).The event of spine imbalance is addressed in the ifu as potential risks associated with the mid-c system 1.Curve progression above or below the implant 2.Lordosis/kyphosis changes.

• 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: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 12954650
• MDR Text Key: 281909603
• Report Number: 3013461531-2021-00042
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

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 Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-01-069-21
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 12/13/2021
• Date Device Manufactured: 01/28/2021
• 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