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

Catalog Number 48289999

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is currently unknown.

Event Description

It was reported that the right l5 mantis es2 blocker 'came loose' a few weeks post-operatively.Revision surgery has occurred.

Event Description

It was reported that the right l5 mantis es2 blocker 'came loose' a few weeks post-operatively.Revision surgery has occurred.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device associated with this record was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Initial report states a posterior fixation following a traumatic l4 rupture was performed about a month ago.L3-5 were fixed and the surgery was completed, but after a few weeks, the set screw on the right side of l5 came loose.The reported event was not confirmed because the device was not returned and no x-rays were provided of the event.It was further reported that the final tightener and anti-torque instruments were used and neither had any damage.The mantis redux surgical technique was reviewed: construct tightening: ¿once the correction procedures have been carried out and the spine is fixed in satisfactory position, the final tightening of the blocker is done by utilizing the counter torque tube and torque wrench.¿ note: prior to final tightening, ¿please ensure that: the rod is horizontally placed into the screw head, that the rod is not high in the screw head and an acute convex or concave bend is not contoured into the rod.¿ due to no product return or x-ray provided, a root cause could not be determined conclusively.

• 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 Key: 13559996
• MDR Text Key: 288207179
• Report Number: 0009617544-2022-00018
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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 Catalogue Number: 48289999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/23/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Male