FDA Adverse Event Injury Summary report: N

STRYKER SPINE SERRATO ROD

MDR report key: 10842789 · Received November 16, 2020

Report

Report Number
10842789
Event Type
Injury
Date Received
November 16, 2020
Date of Event
August 28, 2020
Report Date
September 25, 2020
Manufacturer
STRYKER CORPORATION
Product Code
NKB
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

FAILED IMPLANTED HARDWARE (IMPLANTS- PEDICLE SCREWS, RODS, AND SET SCREWS) PATIENT REQUIRED SURGERY FOR REMOVAL/ REPLACEMENT OF HARDWARE ORIGINALLY PLACED [DATE REDACTED], REMOVED [DATE REDACTED]. PATIENT RETURNED TO SURGERY WITHIN 18 DAYS DUE TO DEVICE FAILURE. PT PRESENTED WITH COMPLAINT OF RIGHT LEG PAIN- WORSE SINCE SURGERY. FAILED HARDWARE WAS REMOVED AND REPLACED WITH NEW HARDWARE. PATIENT WAS TREATED WITH ANCEF 2GM IV Q8 (EVERY 8) HOURS DURING HOSPITAL STAY. PATIENT WAS NOT SENT HOME WITH RX (PRESCRIPTION) ANTIBIOTICS. AT DISCHARGE, PATIENT WAS AFEBRILE, ALERT, ORIENTED, AND AT BASELINE, VITAL SIGNS ARE CONSISTENT WITH PRE-ADMISSION BASELINE, PATIENT IS AMBULATORY, TOLERATING PO INTAKE, NO MOTOR OR SENSORY DEFICITS ON EXAM. PATIENT HAS APPROPRIATE TENDERNESS TO INCISION SITES, AND PATIENT DENIES SEVERE PAIN. PATIENT'S PAIN IS CONTROLLED ON ORAL MEDICATIONS. PATIENT HAS BEEN GIVEN DISCHARGE AND WOUND CARE INSTRUCTIONS ALONG WITH STRICT RETURN PRECAUTIONS THAT ARE PERTINENT TO THIS ADMISSION AND SURGICAL PROCEDURE. MANUFACTURER HAS NOT FOLLOWED UP WITH OUR FACILITY. PATIENT REFUSED TO RELEASE THE HARDWARE TO THE MANUFACTURER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1314061 STRYKER SPINE SERRATO ROD STRYKER SPINE SERRATO IMPLANTS (PEDICLE SCREWS, RODS, AND SET SCREWS) NKB STRYKER CORPORATION SERRATO

Patients

Seq Age Sex Outcome Treatment
1 29565 DA Hospitalization| R