MAUDE Adverse Event Report: STRYKER SPINE-US DIAPASON ROD 120 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 665120

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

It was reported that a 120mm and 140mm diapason rod disengaged from the respected cross connector 2 years post-operatively and was discovered via x-ray.Revision surgery was performed and device remains implanted.This record represents the 120mm diapason rod.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.During the revision surgery it was discovered that both sides of the connector were disconnected from the diapason rod.It was reported that the load on the connector of the axial part was released and the rod came off from the connector.Additional rods were added to each left and right sides and four parallel rods were used.The rod that disengaged from the connector remains implanted.Since the rod migration was noticed approximately two years after the initial surgery and the patient did not fuse the most likely cause of the reported event is delayed healing.Per the surgical technique: delayed union or nonunion - internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.

Event Description

It was discovered via x-ray that a 120mm and 140mm diapason rod disengaged from the respected cross connector 2 years post-operatively.Revision surgery was conducted where reinforcement and bone grafting was performed to disperse the mechanical load.The diapason rod remains in the patient.This record represents the 120mm diapason rod.

• Brand Name: DIAPASON ROD 120 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9858128
• MDR Text Key: 184266745
• Report Number: 0009617544-2020-00042
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540320360
• UDI-Public: 04546540320360
• Combination Product (y/n): N
• PMA/PMN Number: K060361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 665120
• Device Catalogue Number: 665120
• Device Lot Number: 191799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention