MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PCD PREC SYS LONG TUBE W/VPLX; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	0507486000
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discarded.
Event or Problem Description
It was reported that black rubber from the cement mixer became loose and mixed with the cement.There was a delay of a couple of hours to get a new device.The procedure was completed successfully with no adverse consequences reported.

• Brand Name: PCD PREC SYS LONG TUBE W/VPLX
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9788154
• Report Number: 0001811755-2020-00610
• Device Sequence Number: 16690669
• Product Code: NDN
• UDI-Device Identifier: 37613327357869
• UDI-Public: 37613327357869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: Health Professional
• Device Catalogue Number: 0507486000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1