MID-C 125
Report
- Report Number
- 3013461531-2021-00042
- Event Type
- Injury
- Date Received
- December 7, 2021
- Date of Event
- October 28, 2021
- Report Date
- December 7, 2021
- Manufacturer
- APIFIX LTD
- Product Code
- QGP
- PMA / PMN Number
- H170001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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).
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.
THE SURGEON, ASKD APIFIX'S OPINION ABOUT THE PAITENT FLAT BACK IN THE LUMBAR SPINE, AND AN OVERCORRECTION OF THE LUMBAR SCOLIOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1855651 | MID-C 125 | POSTERIOR RATCHETING ROD SYSTEM,,, | QGP | APIFIX LTD | MID-C 125 | AF-01-069-21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |