MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 2 LEVEL ACP SIZE 30MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number 48651230

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Material Deformation (2976)

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

Event Date 11/07/2016

Event Type  malfunction  

Event Description

It was reported that the gold locking ring on 30mm plate was extracted during removal of screw, had to remove the plate and replace to achieve final tightening/locking.

Manufacturer Narrative

Visual inspection, device history review, complaint history review, risk assessment.The device was not confirmed to have any locking ring of the plate deformed through visual examination.Manufacturing records for this product were reviewed and no anomalies were found.The root cause of the reported event is not determined.

Event Description

It was reported that the gold locking ring on 30mm plate was extracted during removal of screw, had to remove the plate and replace to achieve final tightening/locking.

• Brand Name: REFLEX-HYBRID 2 LEVEL ACP SIZE 30MM
• 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6142589
• MDR Text Key: 61699515
• Report Number: 0009617544-2016-00480
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 04546540534804
• UDI-Public: (01)04546540534804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040261
• 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: 01/27/2017

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 Catalogue Number: 48651230
• Device Lot Number: 14G865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2015
• 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