REFORM TI PEDICLE SCREW SYSTEM
Report
- Report Number
- 3005739886-2024-00052
- Event Type
- Injury
- Date Received
- December 9, 2024
- Date of Event
- October 10, 2024
- Report Date
- November 11, 2024
- Manufacturer
- PRECISION SPINE, INC
- Product Code
- KWP
- PMA / PMN Number
- K150856
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 003
Narratives
H3 DEVICE EVALUATION - ENGINEERING EVALUATION NOTED SCREW LOOSENING AT THE BONE INTERFACE WAS NOTED TO BE OBSERVED AND WAS THE LIKELY CAUSE FOR THIS EVENT, THOUGH FUSION HAD BEEN SUCCESSFULLY ACHIEVED. SCREW LOOSENING IN BONE IS A POTENTIAL ADVERSE EFFECT ASSOCIATED WITH PEDICLE SCREW CONSTRUCTS. JOURNAL ARTICLES NOTE BONE SCREW LOOSENING AND MULTIPLE FACTORS THAT MAY IMPACT THIS OCCURRENCE. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO POOR BONE QUALITY, IMPROPER SCREW PLACEMENT, AND EXCESSIVE STRESS ON THE SCREW. THE NUMBER OF LEVELS FUSED, THE USE OR ABSENCE OF INTERBODY DEVICES, AND THE LOCATIONS OF THE SCREWS IN THE CONSTRUCT CAN PLAY A PART IN THIS WITH SCREWS AT THE ENDS OF CONSTRUCTS BEING MORE PRONE TO LOOSENING. A REVIEW OF THE RETURNED IMPLANTS DID NOT BRING TO LIGHT ANY PRODUCT ISSUES. NO IMAGES WERE PROVIDED FOR REVIEW. THE ROOT CAUSE OF REPORTED LOOSENING COULD NOT BE DETERMINED. THE TULIP ASSEMBLY AND BONE SCREW THAT WERE NOTED AS DISASSEMBLING DURING REMOVAL WERE EXAMINED WITH A 5X LOOP AS WELL AS INSPECTED FOR RING'S BOTTOM INTERNAL DIAMETER, TULIP BOTTOM BORE DIAMETER, AND BONE SCREW SPHERICAL DIAMETER. THE RING OPENING WAS FOUND TO BE .003" OHL. IT IS UNCLEAR IF THIS WAS AN AS MANUFACTURED OR A CONDITION RESULTING FROM IMPLANTATION SINCE THE PART WAS IMPLANTED FOR 11+ MONTHS. GROSS DEFORMATION OF THE RING, THE TULIPS BOTTOM OPENING, OR THE BONE SCREWS' SPHERICAL SURFACE WAS NOT PRESENT WHICH RAISED QUESTIONS WHETHER THE TULIP HAD BEEN PROPERLY ASSEMBLED DURING THE INITIAL IMPLANTATION SINCE TULIP/BONE SCREW ASSEMBLIES SUBJECTED TO SUCH TESTING EXHIBIT GROSS DEFORMATION. REVIEW OF RELEVANT MANUFACTURING HISTORY RECORDS FOUND ALL PRODUCTS WERE MANUFACTURED AND RELEASED FOR DISTRIBUTION WITH NO DEVIATION OR ANOMALIES. TWO-YEAR COMPLAINT HISTORY REVIEW DID NOT REVEAL A TREND FOR REPORTS OF EITHER SCREW LOOSENING OR TULIP DISASSEMBLY UPON REMOVAL. NO CORRECTIVE ACTIONS ARE RECOMMENDED.
D4 LOT NUMBER - UNKNOWN. D4 PRIMARY UNIQUE IDENTIFICATION (UDI) NUMBER - UNKNOWN WITHOUT LOT IDENTIFICATION. H3 OTHER - EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED. H4 DEVICE MANUFACTURE DATE - UNKNOWN WITHOUT LOT IDENTIFICATION.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GUTTER FUSION WITH LAMINECTOMY PROCEDURE ON (B)(6) 2023, UTILIZING THE REFORM TI MODULAR PEDICAL SCREW SYSTEM. NO INTERBODY CAGES WERE USED. SUBSEQUENTLY, A REVISION WAS PERFORMED ON (B)(6) 2024 TO ADDRESS A PAINFUL, LOOSE CONSTRUCT (SCREWS LOOSENING IN THE BONE). IT WAS NOT CLEAR HOW MANY OF THE SCREWS WERE LOOSE. UPON ATTEMPTED REMOVAL OF ONE OF THE PEDICLE SCREWS, THE MODULAR TULIP DISASSEMBLED FROM THE SCREW. ALL EXISTING.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GUTTER FUSION WITH LAMINECTOMY PROCEDURE ON (B)(6) 2023, UTILIZING THE REFORM TI MODULAR PEDICAL SCREW SYSTEM. NO INTERBODY CAGES WERE USED. SUBSEQUENTLY, A REVISION WAS PERFORMED ON (B)(6) 2024 TO ADDRESS A PAINFUL, LOOSE CONSTRUCT (SCREWS LOOSENING IN THE BONE). IT WAS NOT CLEAR HOW MANY OF THE SCREWS WERE LOOSE. UPON ATTEMPTED REMOVAL OF ONE OF THE PEDICLE SCREWS, THE MODULAR TULIP DISASSEMBLED FROM THE SCREW. ALL EXISTING HARDWARE WAS REMOVED AND, AS FUSION WAS ACHIEVED, NO NEW HARDWARE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2536135 | REFORM TI PEDICLE SCREW SYSTEM | MODULAR BONE SCREW | KWP | PRECISION SPINE, INC | 39-SB-XXXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Hospitalization| R |