MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE; PROSTHESIS INTERVERTEBRAL DISC

Model Number	09.820.036S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is unknown.Date of device migration is unknown date subsequent to (b)(6) 2018.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(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
It was report that the patient had surgery on (b)(6) 2018 for treatment with a prodisc c (pdc) artificial disc replacement at c4-c5 spine disc level.Patient was implanted with one (1) pdc medium deep 6mm-sterile implant.Post-operatively on an unknown date, during a routine surgeon follow up office visit, the patient presented with a migrated implant.The pdc implant had been displaced/migrated anteriorly and was not fully seated in the cervical disc space.On (b)(6) 2018, the surgeon removed the pdc implant and revised the patient to another, same sized pdc implant.No fragments were generated during implant removal.It was reported that a soft cervical collar (neck brace) that was used post-operatively to support the patient's neck was improperly fitted.Revision surgery was completed successfully with no time delay.Patient is reported in stable condition.This report is for a prodisc-c implant medium deep 6mm-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part: 09.820.036s; lot: h057068; date of manufacture: march 17, 2018; place of manufacture: (b)(4); part expiration date: february 28, 2020; list of nonconformances: n/a.Description of device history record review: no nonconformance reports (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.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.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.
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: PRODISC-C IMPLANT MEDIUM DEEP 6MM-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: 7647890
• Report Number: 2939274-2018-52676
• Device Sequence Number: 157119
• Product Code: MJO
• UDI-Device Identifier: 10705034763767
• UDI-Public: (01)10705034763767
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2018

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 Expiration Date: 02/28/2020
• Device Model Number: 09.820.036S
• Device Catalogue Number: 09.820.036S
• Device Lot Number: H057068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 07/20/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/26/2018; 07/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR