MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 34; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number 48811234

Device Problems Break (1069); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 08/21/2017

Event Type  malfunction  

Event Description

It was reported that locking mechanism was damaged during screw removal.

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assessment; results: visual inspection confirmed the spring bar was deformed.Manufacturing files were reviewed and no anomalies were found.Conclusion: the possible root causes include:screw not fully seated below spring bar, poor visibility of spring-bar, spring-bar damaged prior to use, blocker locked before visual confirmation of screw below spring bar.

Event Description

It was reported that locking mechanism was damaged during screw removal.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 34
• 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: 6870057
• MDR Text Key: 86485330
• Report Number: 0009617544-2017-00358
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152217
• UDI-Public: (01)07613252152217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083562
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48811234
• Device Catalogue Number: 48811234
• Device Lot Number: 171771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2017
• 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