MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48130000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that a xia 4.5 titanium blocker at s2 on the right side has loosened and the rod, "is about to come off." revision surgery has not occurred.
Event or Problem Description
A physician reported that a xia 4.5 titanium blocker at s2 on the right side has loosened and the rod, "is about to come off." revision surgery has not occurred.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject lot and catalog number was performed and no adverse trends were observed.Initial report states that the set screw of the s2ai screw on the right side has come loose, and the rod is about to come off.Device was implanted on 30-nov-2021, 3 months prior to the event.The patient continues to be monitored.It was reported via additional follow ups that the torque wrench and anti-torque wrench were used, no damage noted on either.Blocker did not appear to be cross threaded.It is unknown if rod was fully reduced.It was reported that the angle was potentially difficult, as the rods were just barely long enough.X-ray review confirms blocker migration of the right s1ai blocker.No other blocker migrations are noted on either side.There is little to no rod overhang on both sides of the construct at the s2ai tulips.Xia ifu and surgical technique guide was reviewed: implant selection and use: ¿the choice of proper shape, size and design of the implant for each patient is crucial to the success of the surgery.The surgeon is responsible for this choice which depends on each patient.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.Improper selection, placement, positioning and fixation of these devices may result in unusual stress conditions reducing the service life of the implant.¿ the most likely cause of the reported event was determined to be due to the lack of sufficient overhang of the rods.Little to no rod overhang is observed on either side of construct which may result in construct instability.

• Brand Name: XIA TITANIUM 4.5 BLOCKER
• Common Device Name: 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: 13667409
• Report Number: 0009617544-2022-00027
• Device Sequence Number: 4756346
• Product Code: NKB
• UDI-Device Identifier: 04546540448897
• UDI-Public: 04546540448897
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48130000
• Device Catalogue Number: 48130000
• Device Lot Number: 9C5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 20 KG