MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 57; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 48811357

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/15/2017

Event Type  malfunction  

Event Description

It was reported that; surgeon was doing a 3-6 acdf with a 57mm plate.He initially put all 8 screws in 2/3 of the way, not using the drill guide.He tightened down the screws at the top level and bottom level, and when he went to tighten down the screws at the middle levels, he noticed one of the wings had snapped out of the plate.He backed out all the screws, damaging some of the other locking wings.A new 57mm plates was installed successfully.

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assessment; results: the returned plate was confirmed to have deformed locking mechanisms.Manufacturing files were reviewed and no anomalies were found.Conclusion: the root cause is not using the drill guides as recommended.

Event Description

It was reported that; surgeon was doing a 3-6 acdf with a 57mm plate.He initially put all 8 screws in 2/3 of the way, not using the drill guide.He tightened down the screws at the top level and bottom level, and when he went to tighten down the screws at the middle levels, he noticed one of the wings had snapped out of the plate.He backed out all the screws, damaging some of the other locking wings.A new 57mm plates was installed successfully.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 57
• 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: 6635340
• MDR Text Key: 77520482
• Report Number: 0009617544-2017-00236
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152323
• UDI-Public: (01)07613252152323
• 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: 09/11/2017

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 Model Number: 48811357
• Device Catalogue Number: 48811357
• Device Lot Number: 172296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 05/15/2017
• Supplement Dates FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• 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