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

Catalog Number UNK_SPN

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2015

Event Type  Injury  

Event Description

It was reported that; rods broken implanted into my spine.Both (2) will need to be replaced.

Manufacturer Narrative

Method: no methods performed because device was no properly identified and not returned.Results: no results available because no methods were performed.Conclusion: the root cause of the reported event could not be determined because no device and/or insufficient information were provided for review.

Event Description

It was reported that; rods broken implanted into my spine.Both (2) will need to be replaced.

Manufacturer Narrative

Method: device history review.Device not returned.Results: device history and complaint history could not be performed as the reported device was no properly identified.Images provided for review show two fractured rods.No cat/lot numbers can be identified from the images provided.The patient had several risk factors for the non-union, including a history of smoking, marijuana use, hepatitis c and direct trauma to his surgery site.Spinal fusion hardware is designed to hold the fracture together as it heals.It serves as a temporary fixation device.However, if union, or fusion, does not take place, it can result in the hardware breaking.Conclusion: the event was confirmed.Per clinical consultant's medical review; the non-union caused the fracture of the rods.

Event Description

It was reported that; rods broken implanted into my spine.Both (2) will need to be replaced.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN SPINE PRODUCT
• 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: 5199316
• MDR Text Key: 30330950
• Report Number: 0009617544-2015-00470
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2015

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/14/2015; 08/24/2016
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 77