MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK

Catalog Number MSB_UNK_CAGE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown spinal procedure with cage instrumentation.At an unknown time post-op, it was reported that the cage at l5-s1 had migrated.A revision was done to remove the migrated cage.

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.A review of radiographic images show preop lumbar films show likely osteoporosis, degenerative disc disease and mild scoliosis worst at l4 due to disc collapse.Construct is placed from t12 to s1 with interbody support at l4 and l5.Construct appears in good position.Lateral view subsequently shows migration of the l5 interbody spacer ventrally.Reported loosening of the t12 and s1 screws are noted.Here again the construct is stopped at the thoracolumbar junction making failure of bone/implant interface a significant risk.The lumbosacral articulation is always at risk in longer constructs with osteoporotic patients.It appears that the bone holding the s1 screws gave way, allowing considerable movement at l5 and migration of the cage.

• Brand Name: UNK
• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4010569
• MDR Text Key: 17691112
• Report Number: 1030489-2014-03449
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MSB_UNK_CAGE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2013
• 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): Other
• Patient Weight: 102