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 Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of postoperative implant migration is unknown.Date of original implant is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 a patient underwent a removal of a prodisc-c at c5-c6 on (b)(6) 2018 due to anterior migration (worked its way out) and was causing problems (sore throat) for the patient.The patient was revised to cortical-cancellous acf bone spacer and an anterior cervical plate and screws.Surgical delay and patient outcome are unknown.This report is for one (1) prodisc-c implant medium 5 mm-sterile.This is report 1 of 1 for complaint (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
(b)(4) dhr review: product code: 09.820.025s; lot: h125770; manufacturing site: (b)(4); supplier dhr: n/a; release to warehouse: (b)(4) dhr review required to complete release to warehouse date post sterilization.No nonconformance reports (ncrs) were generated during production.Manufacturing location: (b)(4) implant, released by: (b)(4), manufacturing date: june 20, 2016, expiration date: may 31, 2020, part #: 09.820.025s,lot#: h125770 (sterile) - prodisc-c implant- medium deep 5mm - sterile.Quantity (b)(4).Component parts reviewed and they meet specifications: 09.820.025.1 - interior plate size ld im41 bp-56 - lot: h024933, 09.820.025.2 - superior plate size ld im42 bp-56 - lot: h024940, 09.820.025.3 - inlay large deep 5mm im43 bp-56 - lot: 7921154.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 condition.Scn no: (b)(4), vender sterile (phi), ¿sterility documentation was reviewed and determined to be conforming.¿ product was not returned.Based on the information available, it has been determined that no corrective and 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.

• 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: 7472265
• Report Number: 2939274-2018-51951
• Device Sequence Number: 11066665
• Product Code: MJO
• UDI-Device Identifier: 10705034763729
• UDI-Public: (01)10705034763729
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• 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,Followup,Followup
• Report Date (Section B): 04/10/2018

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: 05/31/2020
• Device Model Number: 09.820.025S
• Device Catalogue Number: 09.820.025S
• Device Lot Number: H125770
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/30/2018; 05/18/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/01/2018; 05/25/2018
• 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