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

Catalog Number 48335314

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/27/2017

Event Type  Injury  

Event Description

It was reported that; a screw from the device backed out of the locking mechanism.Update 4/5/2017.Patient had a revision surgery on (b)(6) 2017.

Manufacturer Narrative

Catalog# 48335314.Risk assessment; device history review, complaint history review and device inspection were not performed because lot # was not provided and the device was not returned.The root cause could not be determined conclusively.

Event Description

It was reported that; a screw from the device backed out of the locking mechanism.Update (b)(6) 2017.Patient had a revision surgery on (b)(6) 2017.

• 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6461069
• MDR Text Key: 71755743
• Report Number: 0009617544-2017-00131
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48335314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• 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
• Patient Weight: 83