FDA Adverse Event Injury Summary report: N

CAPSURE PS3 POLYAXIAL SCREW

MDR report key: 17787788 · Received September 20, 2023

Report

Report Number
MW5145963
Event Type
Injury
Date Received
September 20, 2023
Date of Event
May 8, 2023
Report Date
September 18, 2023
Manufacturer
SPINE WAVE, INC.
Product Code
MNI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

IN A VISIT TO (B)(6) NEURO SURGERY, (B)(6), DUE TO PAIN IN LOW BACK IT WAS DISCOVERED THAT THE PEDICLE SCREWS USED IN A SPINAL FUSION DONE ON ME (B)(6), 2020 HAD BROKEN AND THE FUSION FAILED. I HAVE SINCE LEARNED THAT SPINE WAVE, INC. WAS THE MAKER OF THE SCREWS USED IN MY SURGERY. ACCORDING TO MY OPERATIVE RECORD, SCREWS AND THEIR NUMBERS ARE LISTED AS CAPSURE PS3 LOG84801 POLYAXIAL SCREW, NUMBER USED 6, SPINE WAVE, INC 111, IMPLANTED CAPSURE LOCKING SCREW LOG84801 LOCKING SCREW NUMBER USED 8, SPINE WAVE, INC 111, IMPLANTED CAPSURE LOCKING SCREW LOG84801 POLYAXIAL SCREW NUMBER USED 2, SPINE WAVE, INC 111, IMPLANTED. THERE ARE OTHER ITEMS LISTED SUCH AS RODS AND CHIPS. IN FOLLOW UP VISITS POST SURGERY SHOWED FUSION LOOKING GOOD BUT FOR SOME REASON, THE FUSION FAILED. I WAS TOLD BY ALL OF THE SURGICAL TEAM AND PT (PHYSICAL THERAPY) PROVIDERS THAT THESE TYPES OF FUSIONS WERE SOLID AND THAT TITANIUM SCREWS DID NOT BREAK. HOWEVER, MINE DID BREAK. NOTE - DR. (B)(6) WAS VERY HOSTILE TO ME UPON A FOLLOWUP VISIT TO HIM ON (B)(6), 2023 AFTER THE BREAK WAS DISCOVERED WHEN I ASKED HIM IF THE FAILURE COULD BE DUE TO AN EQUIPMENT FAILURE? HE GRUFFLY STATED THAT SCREWS BREAK ALL THE TIME AND DID I WANT REVISION SURGERY OR NOT? SINCE THEN, I HAD TROUBLE GETTING MY OPERATIVE RECORD FROM (B)(6) HOSPITAL WHICH I HAD REQUESTED IN (B)(6). THEY FINALLY ARRIVED ON (B)(6), 2023. PLEASE CAN YOU INVESTIGATE TO SEE IF THE BREAKS ARE THE FAULT OF THE MAKER, SPINE WAVE, INC OF IF THE SURGICAL TEAM DID SOMETHING WRONG. MY SURGERY TOOK PLACE IN (B)(6) 2020 DURING THE PANDEMIC. NOT SURE IF THAT IS RELEVANT OR NOT. REFERENCE REPORTS: MW5122861, MW5122862.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2261641 CAPSURE PS3 POLYAXIAL SCREW ORTHOSIS, SPINAL PEDICLE FIXATION MNI SPINE WAVE, INC. LOG84801

Patients

Seq Age Sex Outcome Treatment
1 77 YR Female Other| S "RODS AND CHIPS".| ACID REFLUX MEDS.| AMOLODIPINE.| ARMOUR THYROID.| MULTI VITAMIN.| ZYRTEC.