SPINEJACK EXPANSION KIT 5.8MM KE058

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-28 for SPINEJACK EXPANSION KIT 5.8MM KE058 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[179137500] 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. Additional information: 1 device was labeled for single-use. 1 device was not reprocessed or reused. Device not returned.
Patient Sequence No: 1, Text Type: N, H10

[179137501] This report summarizes 1 malfunction event in which the device reportedly would not expand or deploy. 1 event had no known patient involvement or patient impact.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001811755-2020-00167
• MDR Report Key: 9636486
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2020-01-28
• Date of Report: 2020-01-28
• Date of Event: 2019-12-31
• Date Mfgr Received: 2019-12-31
• Date Added to Maude: 2020-01-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. ZACH BAKER
• Manufacturer Street: 4100 EAST MILHAM AVENUE
• Manufacturer City: KALAMAZOO MI 49001
• Manufacturer Country: US
• Manufacturer Postal: 49001
• Manufacturer Phone: 2693237700
• Manufacturer G1: STRYKER INSTRUMENTS-KALAMAZOO
• Manufacturer Street: 4100 EAST MILHAM AVENUE
• Manufacturer City: KALAMAZOO MI 49001
• Manufacturer Country: US
• Manufacturer Postal Code: 49001
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SPINEJACK EXPANSION KIT 5.8MM
• Generic Name: CEMENT, BONE, VERTEBROPLASTY
• Product Code: NDN
• Date Received: 2020-01-28
• Model Number: KE058
• Catalog Number: KE058
• Lot Number: VMSR
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
• Manufacturer Address: 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-28