MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number UNK_SPN

Device Problems Patient-Device Incompatibility (2682); Human Factors Issue (2948)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Date 10/09/2017

Event Type  Injury  

Event Description

It was reported that the surgeon implanted a cage at a cervical of a patient.Since this surgery, the patient suffers allergies on the face.The patient's dermatologist would like to have a sample of the implant to perform allergic tests.

Manufacturer Narrative

Device inspection, device history review and complaint history review could not be performed since the device is still implanted.Due to implant not being returned and no additional information being available it cannot be determined if the allergic reaction is related to the implant.

Event Description

It was reported that the surgeon implanted a cage at a cervical of a patient.Since this surgery, the patient suffers allergies on the face.The patient's dermatologist would like to have a sample of the implant to perform allergic tests.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 6997531
• MDR Text Key: 90931329
• Report Number: 0009617544-2017-00394
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• 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?: Yes
• Date Manufacturer Received: 10/09/2017
• 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