MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Impaired Healing (2378)

Event Date 11/29/2017

Event Type  Injury  

Event Description

It was reported that; in (b)(6), one (b)(6) surgeon would like to get information about allergy & hypersensitivity of screws to show the proportion of patients who are allergic the component of our screw.He has had one patient without healing incision for about 3 weeks so he is considering about the allergy of the screw component.

Manufacturer Narrative

Result: the customer reported event of a screw biocompatibility issue was not confirmed because the surgeon confirmed that the patient's complication was unrelated to the products.No product failure could be confirmed, therefore, a root cause cannot be determined.At this time there is no indication to suggest a product non-conformity.

Event Description

It was reported that;in (b)(6), one (b)(6) surgeon would like to get information about allergy & hypersensitivity of screws to show the proportion of patients who are allergic the component of our screw.He has had one patient without healing incision for about 3 weeks so he is considering about the allergy of the screw component.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7150784
• MDR Text Key: 95917629
• Report Number: 0009617544-2017-00442
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/27/2018
• 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