MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL CORTICAL SCREW 5.0 X 30; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 488515030

Device Problem Material Separation (1562)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is currently unknown.

Event Description

A physician reported that the, "head popped off the shank," of a xia ct polyaxial screw approximately fifteen-months post-operatively.The patient has received medical intervention.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of the device history records and complaint history could not be performed as a valid lot number was not provided and could not be obtained.Per xia ct surgical technique: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.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.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.Due to lack of information, an exact cause could not be determined.Probable causes include: non fusion, patient post op activity, patient bone quality, patient fall, over angulation on screw during initial surgery, etc.If additional information becomes available, this investigation will be reopened and updated.H3 other text : device has been discarded.

Event Description

A physician reported that the, "head popped off the shank," of a xia ct polyaxial screw approximately fifteen-months post-operatively.The patient has received medical intervention.

• Brand Name: POLYAXIAL CORTICAL SCREW 5.0 X 30
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10489416
• MDR Text Key: 205536722
• Report Number: 0009617544-2020-00148
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327134148
• UDI-Public: 07613327134148
• Combination Product (y/n): N
• PMA/PMN Number: K152632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 488515030
• Device Catalogue Number: 488515030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other