MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PRODISC-C IMPLANT MEDIUM 5MM-STERILE; PROSTHESIS INTERVERTEBRAL DISC

Model Number	09.820.025S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted.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.No code available used to capture failure of device to seat properly, causing change to surgical plan.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 the patient had a spine surgery procedure on (b)(6) 2018 where the surgeon was scheduled to use a (pdc) pro-disc c implant.Inter-operative, the pdc implant was unable to be fully implanted due to the surgeon having issues in achieving the acceptable implant spine position.The pdc implant was removed from the disc space.Patient was ultimately revised to a spine fusion construct.Hospital has retained the pdc implant.Surgery was completed successfully with a 20 ¿ minute time delay.Reason for the time delay was due to the surgeon having to break scrub to speak with the patient¿s family due to a risk management requirement.No fragments were generated during the implant removal.No additional medical intervention was required.Patient is reported in stable condition, and surgery was completed successfully.This report is for one (1) prodisc c implant this is report 1 of 1 for (b)(4).

• Brand Name: PRODISC-C IMPLANT MEDIUM 5MM-STERILE
• Common Device Name: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7362012
• Report Number: 2939274-2018-51171
• Device Sequence Number: 1232991
• Product Code: MJO
• UDI-Device Identifier: 10705034763729
• UDI-Public: (01)10705034763729(17)EXPIRATIONUNKNOWN(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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: 09.820.025S
• Device Catalogue Number: 09.820.025S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/22/2018
• 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