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

Catalog Number	48289735
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5796882
• Report Number: 0009617544-2016-00289
• Device Sequence Number: 19006704
• Product Code: MNH
• UDI-Device Identifier: 04546540671240
• UDI-Public: (01)04546540671240
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K1022235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2016

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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2016
• Supplement Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR