MAUDE Adverse Event Report: APIFIX LTD MID-C 95; POSTERIOR RATCHETING ROD SYSTEM,,

Model Number MID-C 95

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.According to the user (surgeon) information analysis the x-ray demonstrates the loosening of the lower screw.Screw loosening can result from several reasons such as screw misplacement, osteolysis, osteolysis secondary to a late infection, and more.At the current time ((b)(6)-2020), the company does not have sufficient information to determine the root cause for the screw loosening.Risk assessment: at the time of this report ((b)(6) 2020), the company's incident rate of screw loosening is (b)(4)% which is well within the rate reported in the literature (cer 727 rev r).

Event Description

The surgeon reported that the patient complains of pain and that an x-ray indicates screw loosening.The surgeon plans to remove the system.

• Brand Name: MID-C 95
• 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: 11075646
• MDR Text Key: 223712400
• Report Number: 3013461531-2020-00021
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993136
• UDI-Public: 7290014993136
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2020

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 Operator: No Information
• Device Expiration Date: 02/26/2019
• Device Model Number: MID-C 95
• Device Catalogue Number: AF95
• Device Lot Number: AF 03-01-14
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/28/2020
• Date Device Manufactured: 02/26/2014
• 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