MAUDE Adverse Event Report: STRYKER SPINE-US OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 48551045

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event Description

A company representative reported that the tulip of an oasys occiput plate assembly fractured post-operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.

Manufacturer Narrative

H6 coding has been updated to reflect investigation conclusion h3 other text : device remains implanted.

Event Description

A company representative reported that the tulip of an oasys occiput plate assembly fractured post-operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.

• Brand Name: OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 17007472
• MDR Text Key: 316351115
• Report Number: 0009617544-2023-00032
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48551045
• Device Catalogue Number: 48551045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male