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

Model Number MID-C 115

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2022

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.Surgeon input: the surgeon, dr.(b)(6) reported that the apifix screw was pulled out by 2-3mm.Supposed reason is the very kyphotic back which caused the pull stress on the screw.The surgeon changed the screw and tried to place her a little bit higher to avoid the stress situation.Risk assessment: the current device screw pull out rate due to any reason is (b)(4) 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)) (cer dms-727 rev u).The risk of the screw pull out has been assessed and found to be acceptable (dms#777 rev q1).

Event Description

Patient 596 had revision surgery on (b)(6) 2022 because of apifix screw pulling out.

• Brand Name: POSTERIOR RATCHETING ROD SYSTEM
• Type of Device: MID-C 115
• 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: 13926197
• MDR Text Key: 288017344
• Report Number: 3013461531-2022-00011
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MID-C 115
• Device Catalogue Number: AF115
• Device Lot Number: AF-07-038-20
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/28/2022
• Date Device Manufactured: 08/04/2020
• 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 Outcome(s): Required Intervention