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

Catalog Number 48811112

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

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

Event Date 10/15/2015

Event Type  malfunction  

Event Description

It was reported that the locking ring on a 12mm aviator cervical plate broke upon implantation.Surgeon explanted the plate and implanted a new one.

Manufacturer Narrative

Visual inspection; functional inspection; device history review; complaint history review; risk assessment; the stryker rep confirmed that the holes were prepared with the drill guide.The likely root cause is the application of cantilever forces on the drill guide during removal of the drill guide as specified in the surgical technique.

Event Description

It was reported that the locking ring on a cervical plate broke upon implantation.Surgeon explanted the plate and implanted a new one.

• 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: 5217841
• MDR Text Key: 31209403
• Report Number: 0009617544-2015-00479
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

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: 156320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2015
• 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