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U.S. Department of Health and Human Services

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

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STRYKER CORPORATION STRYKER SPINE SERRATO ROD STRYKER SPINE SERRATO IMPLANTS (PEDICLE SCREWS, RODS, AND SET SCREWS) Back to Search Results
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.
 
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Brand NameSTRYKER SPINE SERRATO ROD
Type of DeviceSTRYKER SPINE SERRATO IMPLANTS (PEDICLE SCREWS, RODS, AND SET SCREWS)
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct
san jose CA 95138
MDR Report Key10842789
MDR Text Key216376756
Report Number10842789
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSERRATO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/25/2020
Event Location No Information
Date Report to Manufacturer11/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/16/2020 Patient Sequence Number: 1
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