MAUDE Adverse Event Report: APIFIX LTD POSTERIOR RATCHETING ROD SYSTEM; MID-C 105

Model Number MID-C 105

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2022

Event Type  Injury  

Event Description

Apifix received an email from distributor which describes implant upper screw pull out.

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.Risk assessment: the current device screw pull out rate due to any reason is 2.04% (n=13) 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 (0.2%-15.5%) (cer dms-727 rev u).The risk of the screw pull out has been assessed and found to be acceptable (dms#777 rev q1 ).

• Brand Name: POSTERIOR RATCHETING ROD SYSTEM
• Type of Device: MID-C 105
• 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: 13788517
• MDR Text Key: 287611527
• Report Number: 3013461531-2022-00010
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/16/2022

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 Expiration Date: 04/20/2022
• Device Model Number: MID-C 105
• Device Lot Number: AF 04-01-17
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/16/2022
• Date Device Manufactured: 04/20/2017
• 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