MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Only month and year of the surgery is valid.(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

It was reported that on an unknown date in (b)(6) 2016, the patient underwent a scoliosis repair surgery from mid thoracic down to sacrum.Rod and screws were implanted in this surgery.Post-operatively, patient reported of pain after six months of the surgery.Later, the area of two bottom screws looked red on skin, due to which the surgeon planned to take the bottom two screws out.No infection was reported.Finally, a revision surgery was performed in (b)(6) 2016 and the bottom screws were explanted.

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2016: patient presented for neurophysiology consultation with complains of back and right thigh, groin pains and right foot numbness/tingling.On (b)(6) 2016: patient presented with pre-operative diagnosis of severe lumbar spinal stenosis, l3-l4 and l4-l5 (central lateral recess and foraminal).Up and down left l5-s1 foraminal stenosis.Severe scoliotic deformity, lumbar spine with compensatory thoracic curve.Persistent severe low back, bilateral buttock and bilateral lower extremity pain.Sagittal decompensation secondary to lumbar kyphosis and underwent following procedures: insertion of segmental pedicle screw-rod fixation, t10-s1.Insertion of bilateral illiac screws for supplemental fixation to the pelvis/ gelveston extension to the pelvis.Bilateral hemilaminotomies, l3 and l4.Bilateral lateral recess decompressions and foraminotomies, l3-l4 and l4-l5.Harvest of autogenous right illiac crest bone marrow aspirate.Attempted anterior fusion, lumbar spine as well as fusion from t10-s1 with crushed cancellous allograft bone supplemented by autogenous right crest bone marrow aspirate.Indications for procedure: patient with persistent low back, bilateral buttock and bilateral lower extremity pain.In addition of pain, had complaints of sagittal imbalance and thus cannot stand straight.Plain x-rays showed evidence of significant thoracic/lumbar scoliotic deformity with a kyphotic component to the lumbar spine contributing towards the sagittal imbalance.Patient has significant rotation of vertebral bodies (approx.40 degrees) at l2, l3 and l4.The mri scan showed evidence of multilevel disk degeneration, as well as evidence of significant lumbar spinal stenosis that she had at l3-l4 and l4-l5.On the left side at l5-s1 there was some slight up and down foraminal stenosis.Per operative report: ¿¿ a longitudinal incision was made in midline spanning t10-s2.The pedicles of t10-s1 were prepared.Small corticotomies were made at points of entrance to pedicles with a bur.Pedicles were prepared with a pedicle finder.Pedicles were probed with a ball-tip probe and no violations of pedicle walls were detected.The pedicles were measured with a depth gauge and appropriate length of screws was selected which were then inserted into above mentioned pedicles.Harvesting of right illiac crest bone marrow aspirate for a total of 60 cc was done with a jamshidi needle and mixed.The transverse processes and lamina of t10-l2 and transverse process of l3-l5, the lamina of l5 and s1 as well as sacral ala were decorticated meticulously and a large amount of bone graft material was then placed between those structures for the fusion spanning t10-s1.Two rods were contoured and secured to the screws.Some contouring was used to try to achieve as much possible correction of kyphotic part of spine as well as top try to restore lumbar lordosis.X-rays showed instrumentation to be in good position.Prior to inserting the rods, illiac screws were inserted into pelvis bilaterally and connection was made via side connectors.Proceeding with decompression, spinous processes of l3 and l4 were removed.The bone was cleaned of all soft tissue and morcellized and added to fusion.Attention was then directed to lateral recesses and bilateral lateral recess decompression at l3-l4 and l4-l5 was carried out.Bilateral foraminotomies were carried out at l3-l4 and l4-l5.On left side some distraction between l5 and s1 was applied in order to increase vertical height of foramen.Also, as a part of fusion we decorticated the facet joints in the lumbar spine including l1-l2, l2-l3, l3-l4, l4-l5 and l5-s1 and grafted the facet joints for additional surface area for the fusion.The patient tolerated the procedure well and was returned to recovery room in satisfactory condition.¿ on (b)(6) 2016: the patient was in icu post op due to high blood loss.The patient was experiencing some nausea and was doing better from a pain management (neuropathic back pain radiating to right leg) standpoint.The patient was post-op anemia symptomatic.On (b)(6) 2016: the patient presented with painful iliac screws bilaterally.Failure of conservative care.Status post thoraco lumbar fusion for treatment of scoliosis and stenosis.The patient underwent removal of bilateral screws.Post-op diagnoses: painful iliac screws bilaterally.Failure of conservative care.Status post thoracolumbar fusion for treatment of scoliosis and ste nosis.Seroma over left iliac screw.Per operative report: ¿¿with the help of c-arm, the area corresponding to the iliac screws was identified.Indeed, the left one had a large bursa over it.An incision was made over the iliac screws, one on the left, and one, on the right.On the left side, the bursa was filled with fluid under pressure.The fluid drained immediately.The 2 iliac screws were exposed.The connection was disassembled by removing the set screws.The connector with the cut on the distal aspect of the rods was removed, one on the left, and one on the right.Both the iliac screws were removed using a screwdriver¿¿the patient tolerated the procedure well.On (b)(6) 2017: the patient presented with probable lumbar pseudoarthrosis, l5-s1.Loosening of s1 pedicle screw fixation bilaterally.Fracture right groin between l5-s1.Status post thoracic and lumbar fusions for the treatment of severe kyphoscoliosis.Recurrent right-sided lumbosacral pain.Failure of extensive conservative care.The patient underwent the following procedures: removal of the distal fractured rod, right l5-s1.Patching of rod, right l5-s1.Removal of s1 pedicle screws bilaterally.Re-instrumentation s1 pedicle screws bilaterally.Redo posterolateral fusion l5-s1 on the right with crushed cancellous allograft bone supplemented by autogenous right iliac crest bone marrow aspirate.Post-operative diagnoses: probable lumbar pseudoarthrosis, l5-s1.Loosening of s1 pedicle screw fixation bilaterally.Fracture right groin between l5-s1.Status post thoracic and lumbar fusions for the treatment of severe kyphoscoliosis.Recurrent right-sided lumbosacral pain.Failure of extensive conservative care.Pseudoarthrosis on the right, l5-s1.Solid fusion on the left at l5-s1.Indications for procedure: the patient initially did very well after the surgery.Thereafter, had discomfort over the illiac screws which were removed.Subsequently, developed left sided sacral fracture which eventually healed.The patient then started having symptoms on the right lumbosacral area.X-rays were obtained, which showed evidence of fracture of the right l5-s1 rod.A ct scan was obtained and it couldn¿t be sure whether the fusion was solid at l5-s1 per operative report: ¿¿a longitudinal incision was made in the midline spanning l3 to s2.The fractured rod was identified on the right between l5-s1.The right s1 screw was grossly loose.The set nut was removed and the distal fractured end was removed.The rod was also removed and advancement screw was removed with a screwdriver.A new screw was then inserted, of a larger diameter which obtained excellent purchase at the sacrum.The rod on the left side was detached and the s1 screw with a new larger diameter was placed.The left s1 screw was also removed.¿ intra-operative course was uneventful.On (b)(6) 2017: the patient was reported to be doing well other than urinary retention.The patient had tolerable pain, 4-5/10.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6669165
• MDR Text Key: 78442234
• Report Number: 1030489-2017-01634
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2017
• 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
• Patient Outcome(s): Required Intervention