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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS REDUX BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US MANTIS REDUX BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 48289999
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2021
Event Type  Injury  
Event Description
It was reported that on ct immediately after surgery, showed that the screw blocker of the left s2 was coming loose.The patient was taken back into the surgical suite and anesthesia was added, the wound was reopened, and the screw and blocker were replaced with new ones.This led to a 20-30 minute delay.This report will cover the blocker.
 
Manufacturer Narrative
Visual: visual inspection was performed.Deformation and wear marks are observed on the bottom of the blocker.Deformation from rod was deeper on one side of the blocker than the opposite side.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per xia 3 stg: the blocker is assembled onto the universal tightener for insertion.The universal tightener is available in three different options; standard, short, and double-ended.Note: the xia 3 universal tightener is not to be used for final tightening.Once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.The anti-torque key and torque wrench come in two sizes; standard and short.Place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.While the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.The deformation observed indicates 12nm of torque was not obtained, as the rod indentations are not present or less deep than expected.There are chattering/wear marks that also indicate the blocker was not completely tightened to 12nm.Associated screw was inspected as well and was found to have deformation in the screw shank head indicating high angulation of rod in the tulip head.Evidence from blocker and screw both indicate rod was not properly aligned in the tulip head.The most likely cause of the reported event was determined to be under tightening of the blocker during final tightening.Additionally, uneven placement of the rod into the tulip head may have contributed to the event.
 
Event Description
It was reported that on ct immediately after surgery, showed that the screw blocker of the left s2 was coming loose.The patient was taken back into the surgical suite and anesthesia was added, the wound was reopened, and the screw and blocker were replaced with new ones.This led to a 20-30 minute delay.This report will cover the blocker.
 
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Brand Name
MANTIS REDUX BLOCKER
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key12362979
MDR Text Key268037142
Report Number0009617544-2021-00136
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540671431
UDI-Public04546540671431
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092631
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number48289999
Device Catalogue Number48289999
Device Lot Number24L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/26/2021
Initial Date FDA Received08/24/2021
Supplement Dates Manufacturer Received11/13/2021
Supplement Dates FDA Received12/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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