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

Catalog Number UNK_SPN

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2015

Event Type  malfunction  

Manufacturer Narrative

Remains implanted.

Event Description

It was reported through an article titled "screw augmentation for spinopelvic fixation in neuromuscular spine deformities: technical note" that ¿postoperative ct scans revealed two limited lateral leakages of resin" in two (2) patients.The device information for these events was provided as 'cortoss'.Implant dates ranged from june 2013- january 2014, no further information provided.The surgeon stated that "no mechanical failure of the construct was noted during follow-up[s]" and that the ".Two limited lateral resin leakages [occurred] without clinical consequences".

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the biologic was not returned as it remains implanted in the patient.Device and complaint history records could not be reviewed as the lot number was not provided.Per the cortoss 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.Per the clinical article, no intraoperative radioscopic control was used during the screw augmentation procedure.This is most likely the contributing factor to the reported leakage as the surgical technique requires the use of real time imagining during injection.In addition, per the risk file, causes contributing to cement leakage inlcude: low viscosity, increased filling pressure, overfilling, pipes formed when removing catheter.

Event Description

It was reported through an article titled "screw augmentation for spinopelvic fixation in neuromuscular spine deformities: technical note" that ¿postoperative ct scans revealed two limited lateral leakages of resin" in two (2) patients.The device information for these events was provided as 'cortoss'.Implant dates ranged from (b)(6) 2013-(b)(6) 2014, no further information provided.The surgeon stated that "no mechanical failure of the construct was noted during follow-up[s]" and that the".Two limited lateral resin leakages [occurred] without clinical consequences".

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 11624837
• MDR Text Key: 251409483
• Report Number: 0002530131-2021-00001
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: K080108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1