MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL FIXATION ANCHOR, 26MM, BLUE CARTRIDGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48922600

Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported was determined to be user related.

Event Description

It was reported that the surgeon doubled-up on anchors at the same site which caused an anchor to penetrate through the vertebral body.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to be user related.

Event Description

It was reported that the surgeon doubled-up on anchors at the same site which caused an anchor to penetrate through the vertebral body.

• Brand Name: AERO AL FIXATION ANCHOR, 26MM, BLUE CARTRIDGE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 5248062
• MDR Text Key: 32097533
• Report Number: 0009617544-2015-00497
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133328
• 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: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48922600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2015
• 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 Age: 44 YR