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

Catalog Number UNK_SPN

Device Problems Break (1069); Detachment Of Device Component (1104); Material Integrity Problem (2978); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  Injury  

Event Description

It was reported that; the customer reported that the occipital plate broke after implantation and that one of the connectors connecting the plate and the rod has broken off.The surgeon reported that the patient had heard a clicking noise.The surgeon plans to revise the patient.

Manufacturer Narrative

Method:risk assessment; results: device history, visual inspection and manufacturing review were not reviewed because no parts or lot numbers were provided.Conclusion: the root cause could not be determined due to lack of patient information.

Event Description

It was reported that; the customer reported that the occipital plate broke after implantation and that one of the connectors connecting the plate and the rod has broken off.The surgeon reported that the patient had heard a clicking noise.The surgeon plans to revise the patient.

• 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: 6384558
• MDR Text Key: 69279924
• Report Number: 0009617544-2017-00077
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• 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