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

Model Number	488515030
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is currently unknown.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10489416
• Report Number: 0009617544-2020-00148
• Device Sequence Number: 2816083
• Product Code: NKB
• UDI-Device Identifier: 07613327134148
• UDI-Public: 07613327134148
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: 488515030
• Device Catalogue Number: 488515030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other