MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 70 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482316570
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the iliac bolt implanted in (b)(6) 2018 backed out/failed.The iliac bolt was removed on (b)(6) 2018.Offset connector and set screw were removed also.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence with the rep.The device was returned for evaluation.Lot number was not provide.Device evaluation, complaint history review and device history review could not be performed.The patient's post-op activity level is unknown.It is unknown if the patient did any strenuous activity or if the patient fell.No x-rays, surgical notes or pictures provided.It is unknown if the patient fused.There were no known complications during initial surgery.The surgeon final tightened the blocker to 12 nm using line to line audible torque wrench.The screw hole was prepared using gearshift and possible tap.The surgical technique states "while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, 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.Delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.If a nonunion develops or if the implants loosen, bend or break, the device(s) should be revised or removed immediately before serious injury occurs.Conclusion: some of the potential root causes for reported event include loosening due to length of implantation, bone quality and patient post op activity.However, the exact root cause for the reported event cannot be determined as the device was not returned and insufficient information available.Some of the plausible root causes are: loosening due to length of implantation, bone quality and patient post op activity.
Event or Problem Description
It was reported that the iliac bolt implanted in (b)(6) 2018 backed out/failed.The iliac bolt was removed on (b)(6) 2018.Offset connector and set screw were removed also.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 70 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7870639
• Report Number: 3005525032-2018-00057
• Device Sequence Number: 14007592
• Product Code: NKB
• UDI-Device Identifier: 04546540562289
• UDI-Public: 04546540562289
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 482316570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/27/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1