MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM ROD, STRAIGHT (WITH HEX ENDS) 4.5 X 300MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 186161430S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the patient underwent a spinal surgery.Four rods were used in the construct and two (2) expedium 4.5 rods from a spinal growing rod construct were fractured.The cause of the fracture may have been from cyclical loading which fatigued the rods since it is a fusionless system.The two (2) x 300mm inferior rods fractured.Please note the anchors in this system were trolley screws that require health care (b)(4) special access.The rods are health care (b)(4) approved.Concomitant device: unknown setscrews (part# unknown, lot# unknown, quantity unknown ).This report is for one (1) expedium spine system rod, straight (with hex ends) 4.5 x 300mm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint (b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d4: udi.D11/add'l concomitant products provided for reporting.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM SPINE SYSTEM ROD, STRAIGHT (WITH HEX ENDS) 4.5 X 300MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10623000
• MDR Text Key: 209769879
• Report Number: 1526439-2020-01873
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K131802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: 186161430S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 11/02/2020
• Patient Sequence Number: 1
• Treatment: EXP 4.5 TI ROD 4.5 X 300; EXP 4.5 TI ROD 4.5 X 300; UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention