MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 48230000

Device Problems Loose or Intermittent Connection (1371); Unstable (1667); Migration (4003)

Patient Problem Injury (2348)

Event Date 05/05/2019

Event Type  Injury  

Event Description

It was reported that a patient presented with four loose xia titanium blockers which, ¿generated instability in the spine.¿ this record represents the fourth of the four blockers.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records and complaint history records were reviewed.No relevant manufacturing issues were identified as all units met stryker specifications and no similar complaints were identified.From the xia ifu: the surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the devices.Patients who are overweight may be responsible for additional stresses and strains on the device which can speed up metal fatigue and/or lead to deformation or failure of the implants.The size and shape of the bone structures determine the size, shape and type of the implants.Once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants should be taken into consideration by the surgeon at the time of the choice of the implant, during implantation as well as in the post-operative follow-up period.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidated.This may result in further side effects or necessitate the early removal of the osteosynthesis device.The devices currently cannot be located by the site, so evaluation on the implants could not be performed.Without evaluating the device, a definite root cause cannot be determined.Possible root causes include over/under tightening of the blocker, off loading of the blocker, and/or excessive post op activity.

Event Description

It was reported that a patient presented with four loose xia titanium blockers which, ¿generated instability in the spine.¿ this record represents the fourth of the four blockers.

• Brand Name: XIA 3 TITANIUM BLOCKER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8957979
• MDR Text Key: 156403226
• Report Number: 0009617544-2019-00107
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• Combination Product (y/n): N
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48230000
• Device Lot Number: 72C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention