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); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Information (3190)

Event Date 04/12/2019

Event Type  Injury  

Event Description

It was reported that set screws were noted to be loose post-operatively via x-ray.Patient underwent a revision surgery on (b)(6) 2019 for l4-s1 non-union to l3.

Manufacturer Narrative

A correction to pma/510k was made to the 510k.X-ray provided confirmed that 1 blocker migrated in a construct requiring a revision surgery.Visual inspection confirmed the returned blocker had even rod indentations on both sides of the bottom, indicative of 12nm of torque applied.Functional inspection confirmed the blocker was able to be threaded into a test screw with no issues.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history records were reviewed for the lot number provided and no similar events were identified.It was reported that there were no complications during initial surgery, the stryker approved torque limiting driver was used to 12nm with counter torque.The screws were not at difficult angles.It is unknown what the patient's post op activity was and if the patient experienced a fall.The patient was reported to have very poor bone quality.4 of the 5 blockers returned showed witness marks indicative of 12nm of torque being evenly applied across the blocker.One blocker showed signs of off loading, which means the rod was not evenly seated across the blocker.This could cause this blocker to loosen over time as the blocker did not have even contact on the rod and 12nm was not fully applied across the rod to hold it in place.This can be caused by the rod not being fully seated into the tulip before final tightening.With one blocker not fully tightened, it could cause instability in the construct, leading to the other blockers loosening over time.Additionally, with the patient having very poor bone quality, this would contribute to the overall instability of the construct as the screws and rods would be subject to more movement and forces compared to normal bone.

Event Description

It was reported that set screws were noted to be loose post-operatively via x-ray.Patient underwent a revision surgery on (b)(6) 2019 for l4-s1 non-union to l3.

• 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: 8599994
• MDR Text Key: 144712757
• Report Number: 3005525032-2019-00036
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• 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: 7F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR