MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND (MDR) ANCHOR L LUMBAR STAND ALONE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48666025

Device Problems Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2015

Event Type  Injury  

Event Description

It was reported that; a 25mm screw was placed into the cage and it breached the vertebral foramen causing leg pain.Patient was brought back to surgery and screw was shortened to avoid breaching and to releave the leg pain.

Manufacturer Narrative

Method: device not returned; results: the device is still implant and no lot # was provided.The anchor l surgical technique provides detailed guidance on screw insertion.It was later determined that the leg pain was the result of a torn muscle and was not related to the screw placement.Conclusion: a plausible root cause could not be identified because further follow up indicates that the reported patient pain was not related to the device.

Event Description

It was reported that; a 25mm screw was placed into the cage and it breached the vertebral foramen causing leg pain.Patient was brought back to surgery and screw was shortened to avoid breaching and to relieve the leg pain.

• Brand Name: ANCHOR L LUMBAR STAND ALONE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; la chaux-de-fonds 02300 ; SZ 02300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; la chaux-de-fonds 02300 ; SZ 02300
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5061921
• MDR Text Key: 25192927
• Report Number: 3005525032-2015-00107
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48666025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 64