MAUDE Adverse Event Report: STRYKER SPINE-US 10CC CARTRIDGE; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	2101-0010
Health Effect - Clinical Codes	Embolism (1829); Foreign Body In Patient (2687)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: 10CC CARTRIDGE
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7770534
• Report Number: 0002530131-2018-00001
• Device Sequence Number: 1392382
• Product Code: NDN
• UDI-Device Identifier: 00808232000979
• UDI-Public: 00808232000979
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 2101-0010
• Device Lot Number: A1801052
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1