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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 10CC CARTRIDGE; CEMENT, BONE, VERTEBROPLASTY
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STRYKER SPINE-US 10CC CARTRIDGE; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 2101-0010
Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)
Patient Problems Embolism (1829); Foreign Body In Patient (2687)
Event Date 05/30/2018
Event Type  Injury  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
It was reported that during a procedure to treat a patient¿s bone because it was broken, cortoss was being injected at the l5 level when it migrated into the patient¿s heart.The leakage was noticed with fluoroscopy.The procedure ended early and the patient was put on short term anti-coagulants.The representative noted the material had migrated into a vein when the doctor was trying to put a needle in the other side, and the bone he was hammering the needle on was so hard it caused the material to jiggle loose.It was noted there were no issue with the cortoss material during the procedure.
 
Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via correspondence.Device history review indicated all devices accepted into final stock met specifications.Device evaluation could not be performed as no items were returned.The product remained implanted in the patient.Complaint history review indicated there have been no other similar complaints for this reported lot.There was no issues with device during the actual procedure.Device was used as indicated in ifu.Per the ifu carefully inject 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.Result: the plausible root cause for the reported event based on the information provided is application of excessive force during injection due to hard bone quality what caused product to jiggle lose and leak.
 
Event Description
It was reported that during a procedure to treat a patient¿s bone because it was broken, cortoss was being injected at the l5 level when it migrated into the patient¿s heart.The leakage was noticed with fluoroscopy.The procedure ended early and the patient was put on short term anti-coagulants.The representative noted the material had migrated into a vein when the doctor was trying to put a needle in the other side, and the bone he was hammering the needle on was so hard it caused the material to jiggle loose.It was noted there were no issue with the cortoss material during the procedure.
 
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Brand Name
10CC CARTRIDGE
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7770534
MDR Text Key116700980
Report Number0002530131-2018-00001
Device Sequence Number1
Product Code NDN
UDI-Device Identifier00808232000979
UDI-Public00808232000979
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number2101-0010
Device Lot NumberA1801052
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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