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

Model Number	498.003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown when pain started.Additional product codes are: mni, kwp, kwq, nkb.Complainant device is not expected to be returned for manufacturer review/investigation.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.(b)(4).
Event or Problem Description
It was reported that on (b)(6) 2018, the patient had an l4-ilium posterior spinal fusion with synthes universal spinal system (uss).At an unknown time, the patient developed back pain, and also an adjacent level disc disease above the fusion.The surgeon performed the revision surgery on (b)(6) 2018, then removed all the nuts, collars, and both rods.While removing the rods, the surgeon discovered that the left rod was broken just cranial to the left s1 screw.The surgeon placed a new uss screws at l2 and l3, and contoured new rods, and connected them to the screws from l2-ilium.The surgeon did not replace any of the l4-ilium screws from the (b)(6) 2018 surgery.The procedure was successfully completed.There was no surgical delay and patient consequence.This complaint involves seven (7) devices.This report is 6 of 7 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.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: 7916476
• Report Number: 2939274-2018-53980
• Device Sequence Number: 10977136
• Product Code: MNH
• UDI-Device Identifier: 10705034788579
• UDI-Public: (01)10705034788579
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: 498.003
• Device Catalogue Number: 498.003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR