MAUDE Adverse Event Report: STRYKER SPINE STRYKER CERVICORE DISC; PROSTHESIS, INTRAVERTEBRAL DISC

Model Number S-962805-0

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Debris, Bone Shedding (1803); Disability (2371)

Event Date 02/15/2006

Event Type  Injury  

Event Description

Device 5mm too large for disk space.Incomplete discectomy leaving debris in disk space; permanent disability.Required re-operation (b)(6) 2018 for explant and decompression fusion at l5-6.

• Brand Name: STRYKER CERVICORE DISC
• Type of Device: PROSTHESIS, INTRAVERTEBRAL DISC
• Manufacturer (Section D): STRYKER SPINE
• MDR Report Key: 9569367
• MDR Text Key: 174666111
• Report Number: MW5092115
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-962805-0
• Device Lot Number: 0-PROTOTYPE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 64 YR
• Patient Weight: 66