MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF DRILLING 12MM; IMPLANT-CERVICAL SCREW

Catalog Number 48335312

Device Problems Break (1069); Malposition of Device (2616)

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

Event Date 04/16/2014

Event Type  malfunction  

Event Description

It was reported that during a two week post op visit, the surgeon noticed anchor c screws went beyond the plate of the anchor c cage.A revision procedure has already taken place, also while extracting the cage, the threaded tip of the 8mm inserter broke off into the cage.

Manufacturer Narrative

Method: device history report.Results: the cause is difficult to determine because it is likely multi-factorial, with possible cause in user error.Conclusion: the customer reported event of anchor c diam.3.5mm self drilling 12mm locking ring disengagement was confirmed via sales rep report.This event led to a revision surgery.No new harm/hazard was identified.

Event Description

It was reported that during a two week post op visit, the surgeon noticed anchor c screws went beyond the plate of the anchor c cage.A revision procedure has already taken place, also while extracting the cage, the threaded tip of the 8mm inserter broke off into the cage.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 12MM
• Type of Device: IMPLANT-CERVICAL SCREW
• 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: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3804273
• MDR Text Key: 4583648
• Report Number: 3005525032-2014-00067
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102606
• 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: 04/17/2014

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: 48335312
• Device Lot Number: ?
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2012
• 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