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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN CORTOSS CARTRIDGE, 10CC, OUS; CEMENT, BONE, VERTEBROPLASTY
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STRYKER ORTHOBIOLOGICS-MALVERN CORTOSS CARTRIDGE, 10CC, OUS; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 2101-0000
Device Problem Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2020
Event Type  malfunction  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
A surgeon reported that cortoss cement migrated intra-operatively.Two 10 cc cortoss cartridges were injected sequentially over a period of 10 to 15 minutes into fenestrated screws placed in the t6, t7, t8 and t9 vertebral bodies.Cement delivery was monitored via fluoroscopy using periodic live screening.Progressive cement ¿shadowing¿ was observed clearly in the vertebral bodies around the screw shafts.While screening the cement delivery at t9 the surgeon noticed shadows seeming to move through vasculature.The surgeon suspected extravasation from the vertebral bodies had occurred and performed a ct scan to visualize.The surgeon reported that the epidural veins adjacent to the cement augmented levels appeared to contain cement as did vessels within the lungs.The surgeon reported the following day that the patient was, "awake and seemingly unharmed." no adverse consequences or medical intervention were reported.A total of 10 to 12 cc of cortoss cement was reportedly used in the surgery.This record captures the first of two cartridges.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, and similar complaints were identified.Per the ifu: carefully inject cortoss bone augmentation material into the vertebra through a catheter.Slowly inject in small increments (~1 cc or less) while using real time imagining (i.E.Fluoroscoping visualization).If the material leaks outside the vertebral body, stop the injection and wait until the material sets after 2-4 minutes.The hardened material can become a barrier to further leakage.After the material hardens in the body, delivery can be resumed in the physician determines that the patient's condition is suitable for additional injection.For each new injection, prepare a new catheter and syringe combination with freshly mixed material.The cause for the reported event cannot be determined from the information provided.Possible root causes contributing to cement leakage: low viscosity; increased filling pressure; overfilling.
 
Event Description
A surgeon reported that cortoss cement migrated intra-operatively.Two 10 cc cortoss cartridges were injected sequentially over a period of 10 to 15 minutes into fenestrated screws placed in the t6, t7, t8 and t9 vertebral bodies.Cement delivery was monitored via fluoroscopy using periodic live screening.Progressive cement ¿shadowing¿ was observed clearly in the vertebral bodies around the screw shafts.While screening the cement delivery at t9 the surgeon noticed shadows seeming to move through vasculature.The surgeon suspected extravasation from the vertebral bodies had occurred and performed a ct scan to visualize.The surgeon reported that the epidural veins adjacent to the cement augmented levels appeared to contain cement as did vessels within the lungs.The surgeon reported the following day that the patient was, "awake and seemingly unharmed." no adverse consequences or medical intervention were reported.A total of 10 to 12 cc of cortoss cement was reportedly used in the surgery.This record captures the first of two cartridges.
 
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Brand Name
CORTOSS CARTRIDGE, 10CC, OUS
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
MDR Report Key10190196
MDR Text Key225941708
Report Number0002530131-2020-00001
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
PMA/PMN Number
K080108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Catalogue Number2101-0000
Device Lot NumberA1903028
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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