MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT

Catalog Number UNK_ICO

Device Problem Insufficient Information (3190)

Patient Problem Spinal Column Injury (2081)

Event Date 11/23/2013

Event Type  Injury  

Manufacturer Narrative

The quality investigation is complete.If new information becomes available, a follow-up report will be filed.Device not returned to manufacturer.

Event Description

It was reported during a spine procedure, the patient was injured and required ongoing treatment.No further information was provided at this time.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: UNKNOWN
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5318270
• MDR Text Key: 34115315
• Report Number: 0001811755-2015-04710
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ICO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/22/2015
• 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
• Treatment: UNKNOWN HANDPIECE
• Patient Outcome(s): Other