MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 100MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: mni, kwp, kwq, nkb.Complainant part is not expected to be returned for manufacturer review/investigation.Device history review- part number: 498.104, lot number: 7553570, date of manufacture: 27-mar-2014, place of manufacture: (b)(4) (j&b precision - supplier), part expiration date: n/a.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.No code available used to capture adjacent level disc disease the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2019, the surgeon performed spinal fusion and a posterior revision procedure due to patient had developed an adjacent level disc disease and stenosis above the previous fusion at the l2-l3 level.During a removal of both titanium hard rods from the 2014 surgery, it was discovered that the left rod had broken between l3 and l4.The rod did not break during surgery.It broke at an unknown time prior to the revision surgery.The patient did not have non union because the broken rod went on to heal and have had a solid fusion between l3-l5.  all dates were unknown.The surgeon placed new screws at the l2 level.There were no allegation against the screws.After the decompression, new rods were placed and then connected.The new construct is synthes uss l2-l5.It is unknown if there was a surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: unknown rod (part # unknown, lot # unknown, quantity # 1); unknown screws (part # unknown, lot # unknown, quantity # unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM TI HARD ROD 100MM
• 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: 8675826
• Report Number: 2939274-2019-58504
• Device Sequence Number: 2359320
• Product Code: MNH
• UDI-Device Identifier: 10705034788852
• UDI-Public: (01)10705034788852
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

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: 498.104
• Device Catalogue Number: 498.104
• Device Lot Number: 7553570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/06/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS; UNK - SCREWS
• Outcome Attributed to Adverse Event: Required Intervention