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

Catalog Number UNK_SPN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 09/25/2013

Event Type  Injury  

Event Description

Per attached legal correspondence; "[.]alleging that the plaintiff sustained severe and permanent injuries on (b)(6) 2013 during a spinal surgery [.]" reportable as a serious injury.

Manufacturer Narrative

Method: no evaluations performed.Results: device history review could not be performed as the reported device was no properly identified.Device inspection could not be performed as no device was returned.Complaint history review could not be performed as the reported 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

Per attached legal correspondence; "[.]alleging that the plaintiff sustained severe and permanent injuries on (b)(6) 2013 during a spinal surgery [.]" reportable as a serious injury.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN SPINE PRODUCT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5114892
• MDR Text Key: 27178372
• Report Number: 0009617544-2015-00429
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/01/2015

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?: 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: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• 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
• Patient Outcome(s): Other