MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994)

Event Date 01/01/2010

Event Type  Injury  

Event Description

It was reported that, the patient reported that she had spinal surgery in 2010 and since that time she has been feeling unwell, specifically with pain and itching around the site of implantation and also headaches.The patient reported that she has recently been for allergy testing and that the test results indicate that she has sensitivity to nickel.The surgeon and patient were unaware of any allergy at the time of the surgery.The patient has undergone further surgery since 2010.

Manufacturer Narrative

Method: device not returned.Device history review could not be performed a no lot code was provided.Results: device not returned.Device history review could not be performed a no lot code was provided.Conclusion: no failure mode could be confirmed and therefore a plausible root cause cannot be identified.

Event Description

It was reported that, the patient reported that she had spinal surgery in 2010 and since that time she has been feeling unwell, specifically with pain and itching around the site of implantation and also headaches.The patient reported that she has recently been for allergy testing and that the test results indicate that she has sensitivity to nickel.The surgeon and patient were unaware of any allergy at the time of the surgery.The patient has undergone further surgery since 2010.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: irma gamonal ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4842226
• MDR Text Key: 17537277
• Report Number: 0009617544-2015-00262
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2015
• 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): Required Intervention