• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO 10G CURETTE; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-PUERTO RICO 10G CURETTE; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY Back to Search Results
Model Number 0306620000
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/31/2020
Event Type  malfunction  
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 Description
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had insufficient information received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
10G CURETTE
Type of Device
SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
*  00615
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
*   00615
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key11218301
MDR Text Key229321676
Report Number0001811755-2021-00326
Device Sequence Number1
Product Code OCJ
UDI-Device Identifier07613252574187
UDI-Public07613252574187
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 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
Device Operator No Information
Device Model Number0306620000
Device Catalogue Number0306620000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/31/2020
Initial Date FDA Received01/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-