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

Catalog Number UNK_SPN

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

Patient Problems Bacterial Infection (1735); No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2015

Event Type  Injury  

Event Description

It was reported that t10-iliac xia3 primary surgery was performed.After surgery, infection was confirmed and debridement was performed.It proved to be an infection due to escherichia coli.Second debridement and implant exchange were performed.

Manufacturer Narrative

Method: device not returned; conclusion: no failure of the xia 3 devices was reported by the customer.The patient experienced infection (s4), but it could not be determined if the devices contributed to the event due to lack of information and no devices being returned.As a result, no action will be taken.

Event Description

It was reported that t10-iliac xia3 primary surgery was performed.After surgery, infection was confirmed and debridement was performed.It proved to be an infection due to escherichia coli.Second debridement and implant exchange were performed.

• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4796512
• MDR Text Key: 5820095
• Report Number: 0009617544-2015-00239
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2015

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: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/26/2015
• 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
• Patient Age: 72 YR