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

Catalog Number UNK_SPN

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/21/2015

Event Type  Injury  

Event Description

It was reported a post op visit for a patient of dr (b)(6) noticed two broken rods.Construct was bi-lateral from t4-s1 with iliac bolts.

Manufacturer Narrative

Method: device not returned; results: the returned device was inspected and confirmed to be fractured.Furthermore, review of the correspondence confirms that the device was implanted for over 2 years prior to the event occurring, and that fusion was not fully achieved.Per the ifu, these devices are only meant to provide support during fusion of the spine and cannot be expected to indefinitely withstand the load of normal bone.This means that the construct would have been tasked with bearing the load of the spine for a prolonged period of time.Conclusion: the most likely cause of the reported event is a fatigue fracture due to lack of fusion of the vertebrae.

Event Description

It was reported a post op visit for a patient of dr.(b)(6) noticed two broken rods.Construct was bi-lateral from t4-s1 with iliac bolts.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN 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: 4785595
• MDR Text Key: 15839805
• Report Number: 0009617544-2015-00223
• Device Sequence Number: 1
• Product Code: MNI
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 58 YR
• Patient Weight: 45