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

Catalog Number 48289999S

Device Problem Migration (4003)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2020

Event Type  Injury  

Event Description

A physician reported that a x-ray taken three days after implantation showed a rod had migrated post-operatively.The patient was revised and the physician indicated that the mantis blocker was found to have been cross-threaded in the screw during implant surgery, allowing the rod to migrate post-operatively.

Manufacturer Narrative

Field b5 has been updated to reflect additional information received about the event.Fields d4 (lot number) and d10 (date returned) have been updated to reflect return of the device.

Event Description

A physician reported that a x-ray taken three days after implantation showed a rod had migrated post-operatively.The patient was revised and the physician indicated that the mantis blocker at right-side t12 migrated, allowing the rod to migrate post-operatively.

Manufacturer Narrative

Field b5 has been updated to reflect additional information received about the event.Fields d4 (lot number) and d10 (date returned) have been updated to reflect return of the device.

Event Description

A physician reported that a x-ray taken three days after implantation showed a rod had migrated post-operatively.The patient was revised and the physician indicated that the mantis blocker at right-side t12 migrated, allowing the rod to migrate post-operatively.

Manufacturer Narrative

Visual inspection was performed and dents were noted on the blocker and screw shank head indicate that the blocker was overloaded on one side and the rod was not fully contacting the blocker.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints were identified for this lot.The bone quality of the patient was reported to be good.Surgery notes from both the initial and revision surgery were provided.The surgery notes from the initial surgery indicated that the insertion of the screws was more difficult and time-consuming overall because of the anatomical conditions and degenerative changes present.No other complications were noted in either surgery.Per inputs from stryker spine medical director, the screws may not have a good purchase in the pedicle."unless undue force was applied, for a screw to pullout so soon after the initial surgery would be very unlikely.If a significant deformity was present and given the fact that the scoliosis was completely corrected, some significant force may have been applied.Secondly, the sagittal vertical line in the post-operative x-rays is still significant and given the thoracic kyphosis, there would be more force on the screws enhancing the ability to pull off." based on inputs from stryker spine medical director, it is likely that the screw did not hold good purchase in the initial surgery.Unstable construct and uneven loading on the blocker may have contributed to the blocker migration.Other plausible causes include: poor bone quality, incorrect screw trajectory, blocker not tightened to 12nm.

Event Description

A physician reported that a x-ray taken three days after implantation showed a rod had migrated post-operatively.The patient was revised and the physician indicated that the mantis blocker at right-side t12 migrated, allowing the rod to migrate post-operatively.

Manufacturer Narrative

Section b7 has been updated to reflect additional information received regarding the patient's pre-operative diagnosis and index surgery.

Event Description

A physician reported that a x-ray taken three days after implantation showed a rod had migrated post-operatively.The patient was revised and the physician indicated that the mantis blocker at right-side t12 migrated, allowing the rod to migrate post-operatively.

• Brand Name: MANTIS BLOCKER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10176480
• MDR Text Key: 195812921
• Report Number: 0009617544-2020-00093
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K092631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48289999S
• Device Lot Number: 3UJ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR