MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; UNKNOWN SPINE PRODUCT

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/19/2013

Event Type  Injury  

Event Description

It was reported that; plaintiff underwent a posterior arthrodesis to the vertebrae on or about (b)(6) 2012 utilizing stryker instrumentation implementing both allograft and autograft fusion material and placing pedicle screws at t11 and l3.Plaintiff complained about continuing pain to his spine in early 2013 and underwent a removal of the hardware on or about (b)(6) 2013.

Manufacturer Narrative

Method: risk assessment; results: device history, device evaluation review and complaint history review could not be performed as the device was not properly identified.Conclusion: the event could not be confirmed nor the root cause of the reported event determined because no device and/or insufficient information was provided for review.

Event Description

It was reported that; plaintiff underwent a posterior arthrodesis to the vertebrae on or about (b)(6) 2012 utilizing stryker instrumentation implementing both allograft and autograft fusion material and placing pedicle screws at t11 and l3.Plaintiff complained about continuing pain to his spine in early 2013 and underwent a removal of the hardware on or about (b)(6) 2013.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN SPINE PRODUCT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5707566
• MDR Text Key: 46857227
• Report Number: 0009617544-2016-00222
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• 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): Required Intervention