MAUDE Adverse Event Report: ORTHO DEVELOPMENT IBIS PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number 752-6540-26A

Device Problem Unintended System Motion (1430)

Patient Problem Missing Value Reason (3192)

Event Date 07/29/2015

Event Type  malfunction  

Event Description

Subsequent to a posterior lumbar interbody fusion at l4-l5 performed on (b)(6)-2015, the set screw at l4 was found to be loose.On (b)(6)-2015, the set screws and rod were replaced during mini-open surgery.On (b)(6)-2015, the set screw at l4 was found to be loose so another mini-open surgery was performed at which time the pedicle screws at l4 and l5 were replaced along with their set screws and rod.

Manufacturer Narrative

Originally mdr states this date was 11/24/2015, or the date the mdr was submitted.Corrected date for initial contact to ortho development was 10/27/2015.Manufacturer narrative: the device history was reviewed and showed the device was manufactured according to the specification.There is no evidence that the set screw cross threaded.Care must be taken to ensure that the construct is fully tightened and assembled properly.Construct loosening, slippage, or migration is listed as a possible adverse effect in the instructions for use.A definitive cause of the event cannot be determined at this time.

• Brand Name: IBIS PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8016193419
• MDR Report Key: 5248681
• MDR Text Key: 32097602
• Report Number: 1722511-2015-00019
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Model Number: 752-6540-26A
• Device Lot Number: A148554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• 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