MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINEJACK CASE KIT 4.2MM; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	0909000042
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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 investigation type has not yet been determined.Additional information: 1 device is labeled for single-use.1 device was not reprocessed and reused.Device not returned for evaluation.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was difficult to remove.1 event had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.  supplemental rationale corrected data: 1 previously reported event is included in this follow-up record.  product return status 1 device was not available for evaluation.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was difficult to remove.1 event had patient involvement; no patient impact.

• Brand Name: SPINEJACK CASE KIT 4.2MM
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8545828
• Report Number: 0001811755-2019-01340
• Device Sequence Number: 13553257
• Product Code: NDN
• UDI-Device Identifier: 03760253800518
• UDI-Public: 03760253800518
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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 Catalogue Number: 0909000042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 01/01/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1