MAUDE Adverse Event Report: STRYKER SPINE OASYS; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 10/14/2015

Event Type  malfunction  

Event Description

Patient had original anterior cervical diskectomy and fusion (acdf) surgery about three months ago.Patient taken back to or for second acdf surgery because the stryker orthopedic plate and screws were pulling themselves out of the patient's spine.This second surgery was to remove and replace the hardware.

• Brand Name: OASYS
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5203922
• MDR Text Key: 30469496
• Report Number: 5203922
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Other Device ID Number: PLATE 30MM, SCREWS 4.0 X 14MM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2015
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR