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

Catalog Number UNK_SPN

Device Problem Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 12/12/2013

Event Type  Injury  

Event Description

It was reported that a patient complained of an irregular noise when moving to the surgeon.The surgeon is going to perform exploratory surgery on (b)(6) 2013 attempting to locate the source of the squeaking.

Manufacturer Narrative

Method: device not returned; results: the device identity is unknown and no additional information could be obtained.Without the lot #, cat #, and the actual device, further investigation and inspection cannot be performed.As a result, the root cause of the event cannot be determined conclusively.Conclusion: the customer reported event of a xia 3 device squeaking was confirmed via the correspondence with the sales rep.However, no device has been returned for evaluation.The event resulted in no harm to the patient.

Event Description

It was reported that a patient complained of an irregular noise when moving to the surgeon.The surgeon is going to perform exploratory surgery on (b)(6) 2013 attempting to locate the source of the squeaking.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN SPINE PRODUCT
• 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: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3558266
• MDR Text Key: 4101361
• Report Number: 0009617544-2014-00015
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2013
• 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