MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTSTIRE_PRODUCT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number UNK_ICO

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Extravasation (1842)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Product implanted in patient.

Event Description

It was reported as part of a literature review that the stryker bone cement migrated from the vertebral body of the patient.It was also reported that due to complications within the patient the expired 6 months post surgery.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

H6: the quality investigation is complete.H3 other text : product implanted in patient.

Event Description

It was reported as part of a literature review that the stryker bone cement migrated from the vertebral body of the patient.It was also reported that due to complications within the patient the expired 6 months post surgery.It was further reported that the procedure was completed successfully.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16316114
• MDR Text Key: 309010847
• Report Number: 3015967359-2023-00374
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ICO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other