MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS SCREW MULTI-A 6.75 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	486611640
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Injury (2348)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stryker was made aware of a related device complaint on (b)(6) 2019 (mrn 3004024955-2019-00004).On (b)(6) 2019, additional information was provided to stryker indicating a complaint related to a concomitantly implanted screw.Three catalog numbers were provided for the screw, 48611640, 486611645, and 486611650; it is unknown which catalog number pertains to this device.Catalog number 48611640 has been populated in this report.This device information will be updated in a supplemental report upon receipt of additional clarifying information from the reporting physician.
Event or Problem Description
The device was implanted (b)(6) 2016.The patient began to experience discomfort attributed to the concomitantly implanted cage in (b)(6) 2017.Revision surgery was performed to address the concomitant device on (b)(6) 2019.During revision, the physician noted that this device (l4 screw) was, "slightly loose," then removed and replaced it.
Event or Problem Description
The device was implanted (b)(6) 2016.The patient began to experience discomfort attributed to the concomitantly implanted cage in (b)(6) 2017.Revision surgery was performed to address the concomitant device on (b)(6) 2019.During revision, the physician noted that this device (l4 screw) was, "slightly loose," then removed and replaced it.
Additional Manufacturer Narrative
Visual, dimensional, functional and materials analysis could not be performed as the device was not returned.A review of complaint and device history records could not be performed as a valid lot code was not provided and could not be obtained.The updated information from the operation notes and review of primary surgery records states that one screw was "slightly loose." this cannot be confirmed based on images received.Not returned by hospital.

• Brand Name: RADIUS SCREW MULTI-A 6.75 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8563273
• Report Number: 0009617544-2019-00062
• Device Sequence Number: 19380965
• Product Code: NKB
• UDI-Device Identifier: 04546540544483
• UDI-Public: 04546540544483
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K062270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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 Catalogue Number: 486611640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 82