MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF DRILLING 14MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48335314

Device Problem Device Slipped (1584)

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

Event Date 01/13/2015

Event Type  malfunction  

Event Description

It was reported that; outer ring of screw popped off during screw insertion thru aiog.

Manufacturer Narrative

Method: device not returned; results: the device was not returned for device inspection.Surgical technique mentioned: applying excessive cantilever force to the guide/inserter tip may cause damage to the instrument.In addition, excessive pivoting or angulation on the screwdriver while attached to the screw should be avoided as it can cause damage to the screwdriver and/or screw.Conclusion: a possible cause of the reported event is likely user related.

Event Description

It was reported that; outer ring of screw popped off during screw insertion thru aiog.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 14MM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4486907
• MDR Text Key: 21239058
• Report Number: 3005525032-2015-00010
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2015

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: Other
• Device Catalogue Number: 48335314
• Device Lot Number: CANNOT READ. SENDING PRODUCT B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 02/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2015
• 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 Age: 43 YR