MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK

Device Problems Break (1069); Migration or Expulsion of Device (1395)

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

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

It was reported that on: (b)(6) 2015: the patient presented with a complaint of back pain.On (b)(6) 2015: the patient presented with pre-op diagnosis: lumbar degenerative disc (l3-l4) and underwent the following procedures: oblique approach for anterior lumbar interbody fusion, l3-l4 with discectomy and subsequent placement of peek cage, 14 mm x 50 mm x 22 mm with 6 degree lordosis packed with putty and subsequent instrumentation with a 40 mm straight plate.As per op-notes, ¿.We then went on the size with templates and then subsequently placed a peek cage 14 mm x 50 mm x 22 mm with 6 degree lordosis packed with putty.Then a 40 mm straight plate was placed after 5.5 x 35, two bolts were placed, one into the l2 and one at l3 and then 2 hex nuts were placed over the device anchoring in place.We then allowed the soft tissue fallback together after removal of our retractor.¿ the patient also underwent the following procedure: lateral lumbar interbody fusion with cage allograft and anterolateral plate l3-l4 for degenerative disc.As per op-notes, ¿.We then prepared for disc removal and fusion.We then used a series of curettes to dissect away the cartilaginous end plate and finally satisfied ourselves that the cartilage had been adequately removed.We sized a spacer sequentially up to 12 mm height and a 50 mm with 6 mm angle covered end plate to end plate in the ap position.We filled the spacer with allograft and impacted into position." the patient also underwent x-ray of lumbosacral 2 or 3 views.Impression: no lumbar spinal fusion hardware complication.On (b)(6) 2015: the patient was discharged from hospital.On (b)(6) 2015: the patient underwent x-ray of lumbosacral 2 or 3 views post-op.Impression: status post prior l4-s1 posterior decompression, interbody fusion with pedicle screws.There is fracture of the s1 screws in the mid portion.L3-l4 lateral fusion with interbody spacer placement.There is displacement of spacer, screws and lateral plate towards left of approximately 17 mm from the vertebral margin.Degenerative changes are noted.Mild anterolisthesis of l4 over l5 approximately 4 mm, l5 over s1 of approximately 3mm.On (b)(6) 2015: the patient presented with lumbago and other specified pre-operative examination.On (b)(6) 2015: the patient presented with back pain.On (b)(6) 2015: the patient was pre-operatively diagnosed with malposition of the cage and loosening of left flank plate and fracture of s1 screws and underwent the following procedures: left lateral removal of l3-l4 plate and screws, reposition cage and insertion of screw.Remove posterior pedicel screws and rods l4-l5 and l5-s1; insertion of posterior pedicle screws and instrumentation l3-l4, l4-l5; posterolateral fusion with allograft dbm and allograft cancellous bone chips l3-l4; neuromonitoring; insertion of rh-bmp2.The patient underwent spine lumbosacral 2 or 3 views status post fusion for disc degeneration.Findings: ap and crosstable lateral portable views of the lumbar spine submitted.The dorsal aspects of the interpedicular screws are now identified involving s1 have been removed.Interpedicular screws involving l3 remains slight anterior listhesis of l4 on l5 and l5 on s1, not grossly changed.As per op-notes, ¿.I then removed the set screws at l4, l5 and s1 bilaterally.We removed the rods, which were peek and then finally removed screws, what was left from the sheared screws at s1 bilaterally, which announced to about a 1-inch screw as opposed to the 2.5 inch screws we placed.We left another inch of screws within the pedicle of s1 bilaterally.We then removed these screws that were set for peak rods at l4 and l5 and replaced them with screws measuring 6.5 mm in diameter x 45 mm length at each one¿¿.

Manufacturer Narrative

Devices of multiple part/lot numbers were implanted during the procedure including: part: unknown screw/ lot: unk (x2).

Manufacturer Narrative

Additional info: image review: multiple images were provided for patient with previous l4-s1 fusion who underwent l3-4 olif procedure.Postoperatively there is failure of the olif plate with interbody graft migration.We do not known the bony fusion status at l4-s1, and broken screws are seen at s1.I suspect that the three local fusion below the olif graft was solid enough to act as a lever arm and that the l3-4 level should have been augmented with posterior instrumentation initially.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6325050
• MDR Text Key: 67212746
• Report Number: 1030489-2017-00290
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/20/2017
• Supplement Dates FDA Received: 02/13/2017; 05/15/2017; 09/29/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 106