MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. LOOP ® SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 2561232

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Tingling (2171)

Event Date 10/13/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a "tlif procedure at l4-l5 and a l4-l5 posterior artrothesis.The loop cage was well positioned inter operatory." approximately 2 weeks post-op, the cage migarated.The patient experienced "leg pain and paraesthesia due to this event".The patient underwent a revision procedure to remove the cage.

Manufacturer Narrative

(b)(4): the device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A review of radiographic images show an l4/5 tlif procedure performed with pedicle screws and a loop cage.The initial films show ideal position of all components.Actual sizing of the cage and tightness of fit cannot be determined via x-ray.The final lateral view verifies migration of the cage posteriorly.There is reported leg pain that has accompanied this retropulsion.The markers within the cage do not show any change in the geometry that would allow migration therefore no specific reason for migration can be provided.

Manufacturer Narrative

Additional information: analysis of the returned device shows that visual and optical examination identified material deformation around the area the inserter interfaces, consistent with implant and subsequent explantation.Dimensional inspection of relevant dimensions confirmed returned implant to be conforming to print specification.After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implant or associated components; unable to determine root cause of the foregoing event from the available information.

• Brand Name: LOOP ® SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4323300
• MDR Text Key: 5249654
• Report Number: 1030489-2014-04697
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K121332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2561232
• Device Lot Number: 0312158W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2014
• 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): Other
• Patient Age: 00061 YR
• Patient Weight: 93