MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; UNKNOWN ROD XIA 3 45MM

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/18/2016

Event Type  Injury  

Event Description

It was reported that; patient received an implant with an interbody peek cage in (b)(6) 2015 during a lumbar fusion surgery.Patient will undergo a metal allergy testing.She thinks some of the metals in the implant are causing her issues.For the testing the patient requires specific types of metals to be tested against.

Manufacturer Narrative

Method:risk assessment: results: device history review, device evaluation and complaint history review could not be performed as no items were returned.Conclusion: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided for review.

Event Description

It was reported that; patient received an implant with an interbody peek cage in (b)(6) 2015 during a lumbar fusion surgery.Patient will undergo a metal allergy testing.She thinks some of the metals in the implant are causing her issues.For the testing, the patient requires specific types of metals to be tested against.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN ROD XIA 3 45MM
• 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: 5654792
• MDR Text Key: 45194405
• Report Number: 0009617544-2016-00186
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• 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
• Date Manufacturer Received: 04/18/2016
• 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): Other
• Patient Age: 40 YR