MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11G CURETTE; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY

Model Number 0306621000

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/31/2022

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event in which the device or cutting accessory fractured.- 1 event had patient involvement; no patient impact.

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 was labeled for single-use.1 device was not reprocessed or reused.

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: h10.1 previously reported event is included in this follow-up record.Product return status: 1 device was received.

Event Description

This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.

• Brand Name: 11G CURETTE
• Type of Device: SPINAL CHANNELING INSTRUMENT, 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16261782
• MDR Text Key: 308531079
• Report Number: 3015967359-2023-00119
• Device Sequence Number: 1
• Product Code: OCJ
• UDI-Device Identifier: 07613252639794
• UDI-Public: 07613252639794
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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 Model Number: 0306621000
• Device Catalogue Number: 0306621000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2022
• Initial Date FDA Received: 01/29/2023
• Supplement Dates Manufacturer Received: 12/31/2022
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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