MAUDE Adverse Event Report: WARSAW ORTHOPEDICS LOOP SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	2561132
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product is not returned to manufacturer for evaluation however x-ray images were submitted which were analysed and their results are " post op films from l4-5 discectomy and placement of interbody graft with fixation using an interspinous process device.Unclear which device was used, but generally spinal fixation is accomplished with pedicle or "cortical" screws.The spinous process device shouldn't be used as a standalone and displacement of the interbody graft is an expected result.".
Event or Problem Description
It was reported that patient with herniated disc at l4-5 underwent discectomy and additional fixation using an interspinous fixation device.Post-op, patient felt acute pain and returned to the hospital.After "tac" scan the surgeon found that the implant was displaced and was compressing the l4-l5 nerve root.Additional surgery was performed to re-position the implant.During the revision surgery a discectomy at l5-s1 was performed and pedicle screws at l4-l5-s1 were implanted.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: LOOP SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6412302
• Report Number: 1030489-2017-00558
• Device Sequence Number: 13684270
• Product Code: MAX
• UDI-Device Identifier: 00643169241923
• UDI-Public: 00643169241923
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K121332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2023
• Device Catalogue Number: 2561132
• Device Lot Number: 0391056W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 86