MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 43; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48811243

Device Problems Bent (1059); Mechanical Jam (2983)

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

Event Date 10/30/2015

Event Type  malfunction  

Event Description

It was reported that screws were being inserted through holes of 43mm 2 level aviator plate.Locking mechanism was noticed by surgeon to be bent.Plate was removed and new 43mm plate was used.

Manufacturer Narrative

Method: risk assessment; results: drill guides were not used (free handing) during the procedure as specified in the surgical technique.Conclusion: the plausible root cause of this event is not using the drill guides as recommended.

Event Description

It was reported that screws were being inserted through holes of 43mm 2 level plate.Locking mechanism was noticed by surgeon to be bent.Plate was removed and new 43mm plate was used.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 43
• 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: 5243451
• MDR Text Key: 32116515
• Report Number: 0009617544-2015-00492
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

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: 48811243
• Device Lot Number: UNKNOWN. THROWN AWAY BY ACCIDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• 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