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

Catalog Number 2101-0000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Spinal Cord Injury (2432)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

The product was reported to be a cortoss 10 cc ous catalog #2101-0000, lot #a1903028.Inspection and device evaluation could not be performed because the product was not returned.A review of product history identified no relevant manufacturing issues and a review of complaint history identified no similar complaints.The cortoss ifu includes the following: pedicle screw augmentation requires application of cortoss in a specific sequence.If one level is being treated, the first augmented screw in a given vertebra must be allowed to cure before the second screw of the same vertebra is augmented.This is because of the pressure gradients that may occur in the enclosed vertebral space.Alternating lateral and a/p views should be used to ensure that the filling volume is visualized.If more than one level is being treated, each level must be completed sequentially on one side before treating the other side, i.E.Treat all screws on the left side, followed by all screws on the right side or vice versa.In any single vertebra treated with cortoss, one side must be allowed to polymerize (harden) before the contralateral pedicle is augmented.Use of cortoss bone augmentation material is contraindicated in the presence of one or more of the following clinical situations: for screw augmentation: breach of the pedicle wall when augmenting pedicle screws.Injection of cortoss in this situation will carry a high risk of leakage into the spinal canal or neural foramen.Cement leakage may cause tissue damage, nerve or circulatory problems, and other serious adverse events.The surgeon reportedly breached the pedicle on two or three levels; therefore, the most plausible root cause for the reported event is that the pedicle was breached.

Event Description

It was reported that a physician encountered difficulties using cortoss.Per the company representative, the cortoss had 45 minutes to an hour to equilibrate before being used.The patient had poor bone quality and the vertebral bodies were filled with approximately 2 cc of cortoss.The pedicle was breached on two or three levels and cortoss leaked onto the spinal cord.Approximately 1.5 hours after the injection, the patient¿s motor function decreased; noted through neuro monitoring.There was a two- hour extension of surgery as the physician removed the screws, lamina, and cortoss which had leaked along the cord.The patient¿s motor functions completely returned after a couple of hours.The patient's spine was left without instrumentation, with no plans to revise.This record captures the second of two units of cortoss.

• Brand Name: CORTOSS 10CC OUS
• 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: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 9469921
• MDR Text Key: 188507736
• Report Number: 0002530131-2019-00005
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K080108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 2101-0000
• Device Lot Number: A1903028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• 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): Required Intervention