MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM 3.5MM SELF DRILLING 10MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 6741610

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2016

Event Type  malfunction  

Event Description

It was reported that; on (b)(6) 2016, c3-6 fixation was performed.After the surgeon inserted a 3.5mm screw to a cage, a metal fragment was found.The surgeon removed it from the patient and progressed the surgery.

Manufacturer Narrative

Result: explanted metal fragment was not returned for evaluation.Device history review was not performed as the lot # is unknown.No further investigation for this event is possible at this time as the metal fragment was not returned for evaluation.The root cause was not determined.

Event Description

It was reported that on (b)(6) 2016, c3-6 fixation was performed.After the surgeon inserted a 3.5mm screw to a cage, a metal fragment was found.The surgeon removed it from the patient and progressed the surgery.

• Brand Name: ANCHOR C DIAM 3.5MM SELF DRILLING 10MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5957356
• MDR Text Key: 55266940
• Report Number: 3005525032-2016-00109
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6741610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR