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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL PACK (SURGICAL BLADES) ORTHOPEDIC TRAY

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SPINAL PACK (SURGICAL BLADES) ORTHOPEDIC TRAY Back to Search Results
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/30/2019
Event Type  Injury  
Event Description

Surgical blade broke off during lumbar spinal surgery and approx 7mm was retained within the lumbar disc space. Fda safety report id# (b)(4).

 
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Brand NameSPINAL PACK (SURGICAL BLADES)
Type of DeviceORTHOPEDIC TRAY
MDR Report Key8671554
MDR Text Key147294630
Report NumberMW5087140
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/04/2019 Patient Sequence Number: 1
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