MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM 3.5MM SELF DRILLING 10MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 6741610

Device Problems Fitting Problem (2183); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 09/05/2017

Event Type  malfunction  

Event Description

It was reported that; it performed to rock the screw with the inserter.But it was confirmed comfirmed the screwis not fitted in the cage and the locking ring was spread.Replaced another screw and complete the procedure.

Manufacturer Narrative

Visual inspection was preformed and confirmed that the locking ring is deformed.Functional inspection was performed also confirmed the screw is no longer functional.Manufacturing records were reviewed and no relevant issues were identified for the reported lot.Conclusion: the root cause of the reported event cannot be determined conclusively from the information given.

Event Description

It was reported that; it performed to rock the screw with the inserter.But it was confirmed confirmed the screws not fitted in the cage and the locking ring was spread.Replaced another screw and complete the procedure.

• Brand Name: ANCHOR C DIAM 3.5MM SELF DRILLING 10MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6904720
• MDR Text Key: 88032727
• Report Number: 3005525032-2017-00093
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6741610
• Device Lot Number: BWJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• 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
• Patient Weight: 65