MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 30; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48811230

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2017

Event Type  malfunction  

Event Description

It was reported that; a closing bar/wing on a 2 level plate did not move forward properly when the locking nut was final tightened.

Manufacturer Narrative

Method: risk assessment; results: manufacturing files were not reviewed because no lot was provided and no product was returned.Conclusion: the plausible root cause of the reported is not determined.

Event Description

It was reported that; a closing bar/wing on a 2 level plate did not move forward properly when the locking nut was final tightened.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 30
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6490349
• MDR Text Key: 72923748
• Report Number: 0009617544-2017-00148
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152194
• UDI-Public: (01)07613252152194
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• 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