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

Model Number	498.010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient weight not available for reporting.(b)(4).Reported as 2005, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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
The complaint description has been updated: it was reported that the patient had a t10-s2 posterior fusion with synthes universal spinal system (uss) in 2005.At an unknown point in time, the patient broke the right rod between l5 and s1 and a non-union developed.The left rod is intact.The patient also developed proximal junctional kyphosis above the construct.On (b)(6) 2018 the patient underwent a revision and both rods were removed.The right rod fragments were easily retrieved.The left rod was removed related to non-union at the site.The surgeon replaced several screws between t10 and s1 (the size and what screws were replaced are unknown).In addition, the s2 screws were removed.To treat the proximal junctional kyphosis the surgeon placed new screws at t6-t9 and contoured the new rods and connected them to the screws.Iliac screws were placed and connected to the rods.The procedure was successfully completed.No patient harm was reported.This report is for one (1) titanium collar.(b)(4).
Additional Manufacturer Narrative
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.Device used for treatment, not diagnosis.Added the (default) implant date (b)(6) 2005) and explant date (b)(6) 2018).Investigation summary: product was not returned.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.Device was used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: 6.0MM TI COLLAR
• 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: 7403626
• Report Number: 2939274-2018-51525
• Device Sequence Number: 16339830
• Product Code: MNH
• UDI-Device Identifier: 10705034788586
• UDI-Public: (01)10705034788586(10)LOTUNKNOWN
• 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 Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

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: 498.010
• Device Catalogue Number: 498.010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/06/2018; 05/03/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 04/06/2018; 05/04/2018
• 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: 73 YR