MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Although it is unknown if the devices led to the event, we are filing this report for notification purposes.Following devices were involved: part# 54740005530, lot# h5377612, quantity-2.This part is not approved for use in the us, however a like device with part# 54840 005530, 510k# k091974, and udi (b)(4) is approved for market in the us.Part# 54740005535, lot# h5380203, quantity-2.This part is not approved for use in the us, however a like device with part# 54840 005535, 510k# k091974, and udi (b)(4) is approved for market in the us.Part# 54740007545, lot# h5334481, quantity-1.This part is not approved for use in the us, however a like device with part# 54840 007545, 510k# k091974, and udi (b)(4) is approved for market in the us.Part# 54740007545, lot# h5365016, quantity-1.This part is not approved for use in the us, however a like device with part# 54840 007545, 510k# k091974, and udi (b)(4) is approved for market in the us.Part# 3992210, lot# h5244227, quantity-1, 510k# k172199, and udi (b)(4).Part# 3992210, lot# h5299892, quantity-1, 510k# k172199, and udi (b)(4).Part# 3992211, lot# h5226840, quantity-1, 510k# k172199, and udi (b)(4).Part# 3992211, lot# h5281931, quantity-1, 510k# k172199, and udi (b)(4).Part# 7068396, lot# h5350976, quantity-1.This part is not approved for use in the us, however a like device with part# 5440030, 510k# k102555, and udi (b)(4) is approved for market in the us.Part# 7600105, lot# 213086499, quantity-2, 510k# k082917, and udi (b)(4).Part# g9010001425, lot# h5280221, quantity-1, 510k# k153589, and udi (b)(4).Part# 5430030, lot# h5343087, quantity-2.This part is not approved for use in the us, however a like device with part# 5440030, 510k# k102555, and udi (b)(4) is approved for market in the us.Part# 5432025, lot# 0278157w, quantity-1.This part is not approved for use in the us, however a like device with part# 5442025, 510k# k091974, and udi (b)(4) is approved for market in the us.Part# 1475101050, lot# 0503286w, quantity-2.This part is not approved for use in the us, however a like device with part# 1475001050, 510k# k091974, and udi (b)(4) is approved for market in the us.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 patient underwent transforaminal lumbar interbody fusion surgery (tlif) at l4-l5, l5-s; cognitive behavioral therapy (cbt) at l4-l5; screws placement at s1.Post-op, compression fracture at t12-l1 and lumbar spinal canal stenosis at l1-2 were observed.Revision was scheduled to be performed on (b)(6) 2017.Patient developed fever and infection was suspected at the night before the revision surgery.Revision started as scheduled on (b)(6) 2017.During revision surgery, pus came out from the part that was performed in initial surgery which made surgeon determine post-op infection at l4-s and the procedure was changed and washing was performed.No malfunctions were reported against any of these implants.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 6957294
• MDR Text Key: 89566385
• Report Number: 1030489-2017-02225
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2017
• 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: 84 YR
• Patient Weight: 46