MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 26; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 48811226

Device Problems Break (1069); Fracture (1260); Device Slipped (1584); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 07/31/2017

Event Type  Injury  

Event Description

It was reported that; screw backed out at bottom level and wing was broken and screw starting to back out on top level.Patient required revision and was sent to ent to see if there was any damage to the esophagus.

Manufacturer Narrative

Method: risk assessment.Results: visual inspection, functional inspection, and manufacturing files were not reviewed because no lot or parts were provided.The patient's bmi (body mass index) was calculated as 32.6, indicating the weight is in the obese category for adults this height.Conclusion: patient's bmi (body mass index) was calculated as 32.6, indicating the weight is in the obese category for adults this height, so this is the probable root cause of the screw backout and locking mechanism fracture as per the statement in the ifu "surgeons must instruct patients in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity".

Event Description

It was reported that; screw backed out at bottom level and wing was broken and screw starting to back out on top level.Patient required revision and was sent to ent to see if there was any damage to the esophagus.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 26
• 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: 6824046
• MDR Text Key: 83785961
• Report Number: 0009617544-2017-00335
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152170
• UDI-Public: (01)07613252152170
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48811226
• Device Catalogue Number: 48811226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2017
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 100