MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS REDUX BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 48289999

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); No Information (3190)

Event Date 08/28/2017

Event Type  malfunction  

Event Description

It was reported that; blocker came loose post-op and cause rod to migrate.

Manufacturer Narrative

Results: visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the root cause of the event cannot be determined conclusively from the information given.X-ray image was provided but image is not clear.Factors that may have contributed to failure: incorrect alignment of rod in tulip head, inadequate length of the rod (too short) for the construct, repeated fatigue/instantaneous loading, inadequate tightening of the blockers.

Event Description

It was reported that; blocker came loose post-op and cause rod to migrate.

• Brand Name: MANTIS REDUX BLOCKER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6892114
• MDR Text Key: 87455570
• Report Number: 0009617544-2017-00366
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04546540671431
• UDI-Public: (01)04546540671431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092631
• 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: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48289999
• Device Catalogue Number: 48289999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• 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
• Patient Age: 61 YR