MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11G,15MM IVAS KIT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 0705315000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2015

Event Type  Injury  

Event Description

It was reported that during a procedure the outer portion of the needle detached and remained stuck in the patient.A special tool was used to remove it.There were no reported significant delay or adverse consequences.The procedure was completed successfully.

Manufacturer Narrative

The reported condition was confirmed upon evaluation of the returned product.The device was scrapped by the manufacturer.

Event Description

It was reported that during a procedure, the outer portion of the needle detached and remained stuck in the patient.A special tool was used to remove it.There were no reported significant delay or adverse consequences.The procedure was completed successfully.

• Brand Name: 11G,15MM IVAS KIT
• 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; highway #3, km 130.2; kalamazoo MI 49001 006
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4881499
• MDR Text Key: 6257770
• Report Number: 0001811755-2015-02367
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0705315000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2015
• 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
• Patient Outcome(s): Required Intervention