MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK WAVE O CAGE

Catalog Number UNKNOWN

Device Problem Positioning Failure (1158)

Patient Problems Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Ambulation Difficulties (2544)

Event Date 01/28/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

Preoperative diagnosis: lumbar disc disease with facet arthropathy and radiculopathy it was reported that, the patient underwent the following procedures: l3/4, l4/5 minimally invasive transforaminal lumbar interbody fusion.The l3/4, l4/5 pedicle screw/rod fusion.Far lateral transforaminal approach to disc space with right l3/4, l4/5 facetectomy and discectomy.Placement of peek cage at l3/4, l4/5 interbody arthrodesis, placement of allograft and autograft.Reportedly, there was a severe injury to nerves resulting from the placement of the second cage as evidenced by a lack of evoked potentials on intraoperative monitoring from the point of injury through closure and end of the surgery.Immediately postoperatively, patient was unable to move from the waist down.Nerve conduction studies performed (b)(6) demonstrated evidence of severe peripheral nerve injury involving levels l4 through the upper sacral area.Allegedly, the surgeon failed to properly insert and fixate the second cage.Post-op, the patient had severe weakness of both lower extremities and a pronounced loss of balance.The patient required an assistive device for ambulation and had lack of motor movement in the muscles of his legs and feet with noted low tone and marked atrophy.The patient could no longer can maintain an erection nor can he achieve an orgasm.The patient had pain involving both lower extremities, buttocks, rectum, scrotum and testicles.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: WAVE O CAGE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5583854
• MDR Text Key: 42853237
• Report Number: 3003529816-2016-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: SCREW, ROD
• Patient Outcome(s): Other