MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS REDUX REDUCTION SCREW 7.5 X 35MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 48289735

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 06/14/2016

Event Type  malfunction  

Event Description

It was reported that; sales rep : after the setting up 4 screws, the surgeon set up the curved stem length 50 mm and inserted the nut with nut driver.During the final tightening with a torque wrench and anti-torque wrench on the left l5 level, the nut did not hold into the screw head.The surgeon removed the nut and observed that the threads of the screw head (tulip) were damaged.The surgeon removed the nut on the left s1 level, removed the left upper side and the left l5 screw.The surgeon changed the left l5 screw by inserting a new screw dia.7.5 x 40mm ref., then placed another rod, then 2 nuts, and final tightening with a torque wrench.Delay of 15-20 minutes, time to disassemble the left side assembly, repositioning the screw and replace the rod and left final tightening.".

Manufacturer Narrative

Device history review; complaint history review; risk assessment; the product was discarded by the hospital and was not returned.No relevant manufacturing issues found.Conclusion: the root cause of this event is inconclusive since the device is not returned and no inspection could be performed.

Event Description

It was reported that; sales rep : after the setting up 4 screws, the surgeon set up the curved stem length 50 mm and inserted the nut with nut driver.During the final tightening with a torque wrench and anti-torque wrench on the left l5 level, the nut did not hold into the screw head.The surgeon removed the nut and observed that the threads of the screw head (tulip) were damaged.The surgeon removed the nut on the left s1 level, removed the left upper side and the left l5 screw.The surgeon changed the left l5 screw by inserting a new screw dia.7.5 x 40mm ref., then placed another rod, then 2 nuts, and final tightening with a torque wrench.Delay of 15-20 minutes, time to disassemble the left side assembly, repositioning the screw and replace the rod and left final tightening.".

• Brand Name: MANTIS REDUX REDUCTION SCREW 7.5 X 35MM
• Type of Device: PEDICLE SCREW SPINAL 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5796882
• MDR Text Key: 50410139
• Report Number: 0009617544-2016-00289
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540671240
• UDI-Public: (01)04546540671240
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K1022235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48289735
• Device Lot Number: 195203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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 Age: 35 YR