MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482317550

Device Problems Fracture (1260); Mechanical Problem (1384)

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

Event Date 12/07/2021

Event Type  Injury  

Event Description

It was reported that the tulip of a xia 3 polyaxial screw disengaged from the screw shaft approximately 5 years post-operatively.Revision surgery was performed.

Manufacturer Narrative

Visual inspection was performed which confirmed screw shank fractured just below the shank bulb.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The device stg was reviewed and the following was found to be relevant: the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.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.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 most likely cause of the reported event was determined to be the age of implantation and normal wear.Device was active and served its intended purpose for 5 years.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.Excessive strenuous activity or trauma can contribute to screw fractures, but was not confirmed.

Event Description

It was reported that the tulip of a xia 3 polyaxial screw disengaged from the screw shaft approximately 5 years post-operatively.Revision surgery was performed.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM
• 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: 13026848
• MDR Text Key: 282489695
• Report Number: 0009617544-2021-00238
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540562364
• UDI-Public: 04546540562364
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

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 Model Number: 482317550
• Device Catalogue Number: 482317550
• Device Lot Number: B56285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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