MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 18; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811118
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; i was in operating room on the morning of friday, (b)(6) 2017 at 7:30am for an plate and screw removal.After removing the plate, i noticed an eyelet was broken.I informed the surgeon of this.He later found the broken piece inside of the patient and placed it with the plate in a specimen cup, which i have in my possession.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk.Assessment; results: manufacturing files were reviewed and no anomalies were found.Conclusion: the most likely root cause is multifactorial.
Event or Problem Description
It was reported that; i was in operating room on the morning of friday, (b)(6) 2017 at 7:30am for an plate and screw removal.After removing the plate, i noticed an eyelet was broken.I informed the surgeon of this.He later found the broken piece inside of the patient and placed it with the plate in a specimen cup, which i have in my possession.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 18
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6384562
• Report Number: 0009617544-2017-00079
• Device Sequence Number: 744567
• Product Code: KWQ
• UDI-Device Identifier: 07613252152132
• UDI-Public: (01)07613252152132
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 48811118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 05/18/2017
• 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 Weight: 71