MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT

Catalog Number UNK_SPN

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 05/15/2015

Event Type  Injury  

Event Description

It was reported that; afterwards, the patient had lumbago.Therefore, the patient underwent the revision surgery on (b)(6) 2015 (the screws added to t10, t11, t12) (l1 screw changed) (the screw of sacral removed) (the screw added to iliac) (the three rods used).

Manufacturer Narrative

No product issue related to the reported event was found with this product, so this is a concomitant product.

Event Description

It was reported that; afterwards, the patient had lumbago.Therefore, the patient underwent the revision surgery on (b)(6) 2015 (the screws added to t10,t11,t12) (l1 screw changed) (the screw of sacral removed) (the screw added to iliac) (the three rods used).

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4851797
• MDR Text Key: 5811540
• Report Number: 0009617544-2015-00280
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2015

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: Other
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/17/2015
• 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