MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY THREE LEVEL PLATE SIZE 57; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811357
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is still in patient.
Event or Problem Description
Plate was identified with 2 lowest screws backed out.Patient was brought to surgery to remove the two protruding screws.The 2 screws were removed and the plate remains implanted.
Event or Problem Description
Plate was identified with 2 lowest screws backed out.Patient was brought to surgery to remove the two protruding screws.The 2 screws were removed and the plate remains implanted.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence.The device was not returned, therefore product inspection could not be performed.No lot # was provided, so a manufacturing record review could not be performed.Per the report from the rep, patient had a motor vehicle collision.It's unknown when the patient had motor vehicle collision.Conclusion: the root cause of the reported event is likely to be the motor vehicle collision.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 57
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7903561
• Report Number: 0009617544-2018-00231
• Device Sequence Number: 1807749
• Product Code: KWQ
• UDI-Device Identifier: 07613252152323
• UDI-Public: 07613252152323
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: No Information
• Device Catalogue Number: 48811357
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 91