MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNCAGE EVOL MED H17 18¿ PEEK; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	08.825.265S
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event or Problem Description
It was reported on (b)(6) 2019, the syncage evolution peek implant migrated anteriorly post-operatively.Originally, the patient underwent an anterior spinal fusion on an unknown date.The patient's status is unknown.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part: 08.825.265s-us.Lot: 3l58875.Manufacturing site: hägendorf.Release to warehouse date: 05.April 2019.Expiry date: 28.Feb.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) were reviewed, and the complaint condition could be confirmed since the device is seen to have migrated, based on the radiopaque markers.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H6: patient code 3191 used to capture surgical intervention and medical device removal.H6: device code device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNCAGE EVOL MED H17 18¿ PEEK
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9536438
• Report Number: 2939274-2019-62818
• Device Sequence Number: 3337221
• Product Code: MAX
• UDI-Device Identifier: 10705034760506
• UDI-Public: (01)10705034760506
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K122639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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: 08.825.265S
• Device Catalogue Number: 08.825.265S-US
• Device Lot Number: 3L58875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR