MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482317540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A physician reported a patient has been experiencing back pain and imaging indicates two fractured xia 3 polyaxial screws at s1.The patient may need to undergo revision surgery.This record will capture the second of two screws.
Additional Manufacturer Narrative
B.5.Has been updated to reflect revision has occurred.D.4.Has been updated with lot number.
Event or Problem Description
A physician reported a patient has been experiencing back pain and imaging indicates two fractured xia 3 polyaxial screws at s1.Revision surgery has been performed.This record will capture the second of two screws.
Event or Problem Description
A physician reported a patient has been experiencing back pain and imaging indicates two fractured xia 3 polyaxial screws at s1.Revision surgery has been performed.This record will capture the second of two screws.
Additional Manufacturer Narrative
Visual inspection: x-rays were provided showing the tulip separated from the shank on the screws at s1.Upon visual inspection, the screw was fractured at the bulb of the screw shank.Device history records and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The ifu states: 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.It was reported that there were no complications in the original surgery and the screw holes were prepared first with using a high speed spine drill to break the cortex of the bone, then a pedicle probe was used to cannulate the pedicle, followed by sequential tapping up to 1 mm under the screw diameter.No operative notes are available.Information about the patient's bone quality and their post op activity level are unknown.No falls were reported.Root cause is multifactorial with the length of implantation of over 1 year contributing to the event.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10463278
• Report Number: 0009617544-2020-00142
• Device Sequence Number: 2751232
• Product Code: NKB
• UDI-Device Identifier: 04546540562340
• UDI-Public: 04546540562340
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2020

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: Health Professional
• Device Model Number: 482317540
• Device Catalogue Number: 482317540
• Device Lot Number: B55062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/16/2020; 10/31/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 10/16/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR