MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN 10CC CARTRIDGE; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number 2101-0010

Device Problem Insufficient Information (3190)

Patient Problem Embolus (1830)

Event Date 04/09/2015

Event Type  Injury  

Event Description

It was reported that; after procedure patient ended up at the icu with cement emboli in lungs.Patient has had additional testing following the kyphoplasty procedure.

Manufacturer Narrative

Method: device evaluation could not be performed as no items were returned.Device history review and complaint history review.Results: device history review indicated all devices accepted into final stock met specifications.Based on the reviewed patient medical records, the pulmonary embolism post op kyphoplasty procedure was confirmed.Complaint history review indicated there have been no other similar events for the reported lot.The ifu warnings states injecting too much material (over-fill) or injecting the material too quickly may increase the risk of leakage resulting in circulatory complications including, pulmonary emboli.Conclusion: the probable root cause is leakage of the cement into the lungs resulting in the pulmonary embolism experienced by the patient.

Event Description

It was reported that; after procedure patient ended up at the icu with cement emboli in lungs.Patient has had additional testing following the kyphoplasty procedure.

• Brand Name: 10CC CARTRIDGE
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: irma gamonal ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4770898
• MDR Text Key: 20062085
• Report Number: 0002530131-2015-00014
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2101-0010
• Device Lot Number: A1401014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 99