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

Catalog Number 0909000042

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

Discarded.

Event Description

It was reported by the rep that the expander tube had trouble disconnecting from the spine jack implant.There were no adverse consequences and the procedure was successfully completed.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Device unavailable for return.

Event Description

It was reported by the rep that the expander tube had trouble disconnecting from the spine jack implant.There were no adverse consequences and the procedure was successfully completed.

• Brand Name: SPINEJACK CASE KIT 4.2MM
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8323547
• MDR Text Key: 135724362
• Report Number: 0001811755-2019-00538
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0909000042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1