MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNEX(TM) WITH LARGE ENDPLATE 20 DEG/37MM-55MM HEIGHT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	495.323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as 6 feet.Unknown date in 2008.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is an attorney.Part 495.323, lot 1810184: manufacturing site: (b)(4).Release to warehouse date: january 16, 2008.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that surgery was performed on (b)(6) 2008, for treatment a l5 posterior resection due to a hemangioma with a l4-s1 posterior fusion.During this procedure, the patient was implanted with the (uss) universal spine system implants.The patient was implanted with one (1) 6.0mm/ 200mm ti rod that was cut in half to construct two rods, two (2) ti low profile trans-connectors, four (4) nuts, four (4) collars, two (2) 8mm x 55mm screws and two (2) 9mm x 50mm screws.On (b)(6) 2008 patient was brought back to the operating room for a follow-up procedure, where the patient was implanted with one (1) synex cage implant at the l5 spine disc space level.Post-operative, the patient presented with a lumbar spine infection.On (b)(6) 2008, surgeon performed an irrigation and debridement procedure to address the patient's infection.No pus was found intraoperatively.Tissues appeared healthy.Cultures taken during surgery were reported with no organisms seen on gram stain.Surgery was completed successfully.This is report 1 of 8 for (b)(4).The additional 8 parts are being captured on related complaint (b)(4).

• Brand Name: SYNEX(TM) WITH LARGE ENDPLATE 20 DEG/37MM-55MM HEIGHT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7863564
• Report Number: 2939274-2018-53693
• Device Sequence Number: 1431754
• Product Code: MQP
• UDI-Device Identifier: 10705034785110
• UDI-Public: (01)10705034785110
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K003836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 495.323
• Device Catalogue Number: 495.323
• Device Lot Number: 1810184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 113