MAUDE Adverse Event Report: STRYKER CORPORATION STRYKER SPINE SERRATO ROD; STRYKER SPINE SERRATO IMPLANTS (PEDICLE SCREWS, RODS, AND SET SCREWS)

Model Number SERRATO

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 08/28/2020

Event Type  Injury  

Event Description

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.

• Brand Name: STRYKER SPINE SERRATO ROD
• Type of Device: STRYKER SPINE SERRATO IMPLANTS (PEDICLE SCREWS, RODS, AND SET SCREWS)
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10842789
• MDR Text Key: 216376756
• Report Number: 10842789
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SERRATO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2020
• Date Report to Manufacturer: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29565 DA