MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS MULTI-ANGL RAPID SCREW DIA 7.75 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	486618745
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that a radius multi-angle rapid screw placed at s1 fractured post-operatively.Revision surgery has been neither performed or scheduled and no adverse consequence to the patient has been reported.
Event or Problem Description
A physician reported that a radius multi-angle rapid screw placed at s1 fractured post-operatively.Revision surgery has been neither performed or scheduled and no adverse consequence to the patient has been reported.
Additional Manufacturer Narrative
The device remains implanted in the patient; an evaluation can not be performed.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.Initial surgery was performed on (b)(6) 2021.Per additional correspondence, patient did not experience any pain due to the event, patient did not fall post initial surgery, activity level of patient is unknown, bone quality is unknown.No complications were reported during initial surgery.Surgical notes were not provided.From radius surgical technique: the patient must be warned 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) he/she should be warned that resultant forces can cause failure of the device.A root cause of the reported event can not be determined.Excess activity level of the patient, poor bone quality, inadequate initial construct/ too much residual stress on the construct may contribute to this failure.

• Brand Name: RADIUS MULTI-ANGL RAPID SCREW DIA 7.75 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12750872
• Report Number: 0009617544-2021-00217
• Device Sequence Number: 19193050
• Product Code: NKB
• UDI-Device Identifier: 04546540699282
• UDI-Public: 04546540699282
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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 Model Number: 486618745
• Device Catalogue Number: 486618745
• Device Lot Number: 119790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male