MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 250MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight is unknown.Date of event: unknown.Additional device product codes: mni, kwp, kwq, nkb.Initially implanted in (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 the patient underwent a universal spine system (uss) revision on (b)(6) 2018 due to one (1) broken rod and two (2) loose screws.The patient reported that she felt a pop in her lower back in (b)(6).On imaging, the surgeon saw that the patient had broken the right rod just below the s1 screw (broken between s1 and iliac screw).During the revision, the surgeon removed the nuts and collars from the right l5 screw and the right iliac screw.He then replaced the right iliac screw and the right l5 screw.He said that the screws were slightly loose in the bone.He replaced them with new uss screws that were 1 mm larger in diameter.He then cut a new rod and placed an expedium universal connector on the cranial part of the new rod.He then turned the new l5 screw so the side opening faced lateral.He connected the new rod to the existing right rod using the expedium connector between the l2 and l3 screw heads.He then connected the l5 and iliac screws to the new rod.The old right rod ran from t4-s1.The new right rod ran along side the old rod.The patient was initially implanted with the uss hardware from t4-ilium in (b)(6) 2017.No reported delay and no patient consequence.Concomitant devices reported: titanium (ti) nut 11 mm width across flats (part # 498.003, lot # unknown, quantity # 2), 6.0 mm titanium (ti) collar (part # 498.010, lot # unknown, quantity # 2).This report is for one (1) 6.0 mm ti hard rod 250 mm.This is report 1 of 3 for complaint (b)(4).

• Brand Name: 6.0MM TI HARD ROD 250MM
• 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: 7238184
• Report Number: 2939274-2018-50478
• Device Sequence Number: 19087227
• Product Code: MNH
• UDI-Device Identifier: 10705034788890
• UDI-Public: (01)10705034788890(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 498.110
• Device Catalogue Number: 498.110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR