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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 13G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
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STRYKER INSTRUMENTS-KALAMAZOO 13G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) Back to Search Results
Catalog Number 0306130000
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Codes Nerve Damage (1979); Blood Loss (2597)
Date of Event 10/30/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device discarded.
 
Event or Problem Description
It was reported that during a vertebroplasty procedure, that the patient's blood pressure dropped due to the physician cutting a nerve.Medical intervention was necessary for a small chest bleed by inserting a coil to prevent further bleeding.The patient was admitted to the icu.Upon follow up, the initial reporter was not able to provide any further information regarding the reported event.
 
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Brand Name
13G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE
Common Device Name
INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8111656
Report Number0001811755-2018-02562
Device Sequence Number13994678
Product Code OAR
UDI-Device Identifier34546540434303
UDI-Public34546540434303
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Catalogue Number0306130000
Device Lot NumberKQK0
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2018
Initial Report FDA Received Date11/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNK_ICO
Outcome Attributed to Adverse Event Required Intervention;
Patient Age80 YR
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