MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 8.5X80MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802880
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 extraction surgery was performed; the physician indicated, "the bone of the patient was healing." during extraction the physician noted that the head of the screw inserted in the iliac bone was dissociated from the body of the screw.The physician indicated this occurred post-operatively, whilst the device was implanted.The disengaged screw was removed and surgery was completed successfully with no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
On (b)(6) 2019 extraction surgery was performed; the physician indicated, "the bone of the patient was healing." during extraction the physician noted that the head of the screw inserted in the iliac bone was dissociated from the body of the screw.The physician indicated this occurred post-operatively, whilst the device was implanted.The disengaged screw was removed and surgery was completed successfully with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was reported lost.Product and complaint history could not be performed as a valid lot code was not provided and could not be obtained.Complaint history were reviewed and no similar events were identified.Manufacturing history were reviewed and no relevant manufacturing issues were identified.It was reported that a screw disengaged post-operatively due to patient trauma.Therefore, the root cause of the reported event is due to the trauma patient experienced.Surgical technique provides information for the patient: "the surgeon must discuss all physical and psychological limitations inherent to the use of the device with the patient.This includes the rehabilitation regimen, physical therapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion must be directed to the issues of premature weight bearing, activity levels, and the necessity for periodic medical follow-up.The surgeon must warn the patient of the surgical risks and made aware of possible adverse effects.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.Patients who smoke have been shown to have an increased incidence of non-unions.Surgeons must advise patients of this fact and warn of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief." h3 other text : hospital did not return device.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 8.5X80MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8511690
• Report Number: 0009617544-2019-00047
• Device Sequence Number: 1501448
• Product Code: NKB
• UDI-Device Identifier: 07613327002546
• UDI-Public: 07613327002546
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482802880
• Device Lot Number: 166810
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 58