MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI NUT 11MM WIDTH ACROSS FLATS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.878
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.Additional product codes: mni, kwp, kwq, nkb.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is an attorney.Without a lot number the device history records review could not be completed.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 3 of 8 for (b)(4).The additional 8 parts are being captured on related complaint (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.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.
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.Pma/510k: awareness date for follow up 1 should have been september 07, 2018.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: TI NUT 11MM WIDTH ACROSS FLATS
• Common Device Name: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7856865
• Report Number: 2939274-2018-53669
• Device Sequence Number: 1565357
• Product Code: MNH
• UDI-Device Identifier: 10705034791975
• UDI-Public: (01)10705034791975
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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: 498.878
• Device Catalogue Number: 498.003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 09/07/2018; 09/07/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 09/07/2018; 09/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 113