MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 13G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Catalog Number	0306130000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Nerve Damage (1979); Blood Loss (2597)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discarded.
Event or Problem Description
It was reported that during a vertebroplasty procedure, that the patient's blood pressure dropped due to the physician cutting a nerve.Medical intervention was necessary for a small chest bleed by inserting a coil to prevent further bleeding.The patient was admitted to the icu.Upon follow up, the initial reporter was not able to provide any further information regarding the reported event.
Additional Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.
Event or Problem Description
It was reported that during a vertebroplasty procedure, that the patient's blood pressure dropped due to the physician cutting a nerve.Medical intervention was necessary for a small chest bleed by inserting a coil to prevent further bleeding.The patient was admitted to the icu.Upon follow up, the initial reporter was not able to provide any further information regarding the reported event.

• Brand Name: 13G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE
• Common Device Name: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8111555
• Report Number: 0001811755-2018-02561
• Device Sequence Number: 1694004
• Product Code: OAR
• UDI-Device Identifier: 34546540434303
• UDI-Public: 34546540434303
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0306130000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/28/2020
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK_ICO
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR