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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO 10G CURETTE; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY
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STRYKER INSTRUMENTS-PUERTO RICO 10G CURETTE; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY Back to Search Results
Model Number 0306620000
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 12/31/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device was not available for evaluation.1 device was labeled for single-use.1 device was not reprocessed or reused.Device not accessible for testing.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had insufficient information received.
 
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Brand Name
10G CURETTE
Common Device Name
SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
*  00615
MDR Report Key11218301
Report Number0001811755-2021-00326
Device Sequence Number14348235
Product Code OCJ
UDI-Device Identifier07613252574187
UDI-Public07613252574187
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number0306620000
Device Catalogue Number0306620000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/31/2020
Initial Report FDA Received Date01/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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