MAUDE Adverse Event Report: MSD BARTLETT MFG SOVEREIGN SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 7964212

Device Problems Detachment Of Device Component (1104); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation of Vessels (2135); Blood Loss (2597)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the product nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be determined.

Event Description

Pre-op diagnosis: lumbar stenosis procedure: anterior lumbar interbody fusion (alif) levels: l5-s1 it was reported that on (b)(6) 2016, intra-op, while surgeon was placing the trial, trial disengaged from the holder.The patient had significant blood loss and perforated vein or vessel.The perforation of what appeared to be the aorta was repaired to stop the massive blood loss.It was reported that the patient had to return to surgery twice over the weekend to repair a blood flow issue with her leg.

Manufacturer Narrative

(b)(4).Product images were submitted but due to image lighting and quality, in addition to blood and biological material on both instruments, it disallow additional information from being gleaned from the pictures.

Event Description

It was reported that on: (b)(6) 2016: patient presented with internal disruption of l5/s1 disk with intractable pain back and bilateral legs respectively, status post discographic workup.Patient underwent the following procedure: anterior lumbar interbody fusion at l5-s1 with radical discectomy using graft supercharged with rhbmp-2/acs with fluoroscopic supervision during same, and left intra abdominal iliac vein repair.Per-op notes: ¿.I proceeded to graft the l5-s1 space with rgraft as a carrier supercharged with rhbmp-2/acs.¿ intra-operatively,the handle, which was used to place the template, dislodged from the template and hit the patient's iliac vein, resulting in a laceration of the iliac vein.The handle was used to place the template in the disc place, as a measuring device, prior to the insertion of the permanent cage.Allegedly, "as a result of the laceration to the iliac vein, the patient lost 4650 cc of blood before the neurosurgeon and a vascular surgeon in the operative suite were able to repair the iliac vein and stop the bleeding.Because of this event, the cage lumbar fusion was abandoned." reportedly, "following the laceration of the iliac vein, a valiant attempt was made to save the patient's life.A large volume of crystalloids, platelets, fresh frozen plasma (ffp), and other fluids were given to the patient.Once patient was stabilized, patient was transferred to the intensive care unit for follow-up care." allegedly, " an inspection of the template by the surgical technician in the operative suite noted cross-threading between the template and the handle that led to assembly failure between the template and the handle." on (b)(6) 2016: patient presented with left thigh and left calf compartment syndrome.On (b)(6) 2016: patient presented with left medial compartment(adductor) thigh compartment syndrome evolution with malfunctioning wound vac.Patient underwent left medial adductor thigh fasciotomy.Inspection and re-application of 2 wound vacs to the thigh and left(calf) wounds respectively.On (b)(6) 2016: patient presented with swelling on left foot.On (b)(6) 2016: patient presented for wound check.On (b)(6) 2016: patient presented with left thigh lateral wound bed and left medial and left calf wound bed, status post fasciotomies.On (b)(6) 2016: patient presented in the office for repeat wound culture.On (b)(6) 2016: patient presented for two week wound check.On (b)(6) 2016: patient presented for wound check and post-op check.On (b)(6) 2016: patient presented with increased lumbar pain with x rays.On examination patient had sacral tenderness.Patient had cervicalgia, gerd and tenderness over the cervical thoracic junction.On (b)(6) 2016: patient underwent x-rays (b)(6) 2016: patient presented for a follow-up.Patient is reported ambulating without evidence of gait.On (b)(6) 2016: patient presented with pain.On (b)(6) 2016: patient presented with preoperative diagnosis of query left sacroiliitis and underwent left sacroiliac joint arthrogram with fluoroscopic guidance.

Manufacturer Narrative

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

• Brand Name: SOVEREIGN SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• 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: 5485282
• MDR Text Key: 39841142
• Report Number: 1030489-2016-00629
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 7964212
• Device Lot Number: FA09B008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided; 02/19/2016
• Supplement Dates FDA Received: 03/15/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00047 YR