MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 12; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number 48811112

Device Problems Material Separation (1562); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 06/23/2015

Event Type  malfunction  

Event Description

It was reported that; spring bar lifted on a one level aviator plate.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the stryker rep confirmed that some holes were prepared with the drill guide and some weren't, which is the probable cause of the spring bar deformation.The surgical technique recommends the use of the drill guides as it provides the correct angle of trajectory so as not to damage the plate.Conclusion: the root cause is deviation from the recommended technique outlined in the surgical technique.

Event Description

It was reported that; spring bar lifted on a one level aviator plate.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 12
• 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: 5070470
• MDR Text Key: 26073752
• Report Number: 0009617544-2015-00399
• Device Sequence Number: 1
• Product Code: KWQ
• 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: Followup
• Report Date: 06/23/2015

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: 48811112
• Device Lot Number: 147460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2014
• 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