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

Model Number	09.820.046S
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
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 record review has been requested.Code (b)(4) used to capture required surgical intervention and device removal due to adjacent level segment degeneration.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 on (b)(6) 2018, the patient underwent a prodisc-c hardware removal due to adjacent level disease.The surgeon successfully removed the prodisc-c device and the patient was revised to anterior cervical discectomy and fusion (acdf) 2 level.The procedure was successfully completed with no reported surgical delay.There was no other medical intervention required.The patient was stable after the procedure.This report is for a prodisc-c implant large 6mm-sterile.This is report 1 of 1 for (b)(4).
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.A device history record (dhr) review was conducted.Brandywine dhr review: part no.: 09.820.046s, lot no.: 7107185: manufacturing location: brandywine, expiration: 10/2015, release to warehouse date: 5-apr-2013: part 09.820.046s contained ncr for disruption in the cer.The end plates were reworked, no adverse effect to product/ process supported by es0364.The inlays were scrapped (de-issued) and new inlays were issued to the work order.All parts were passed and released.This non-conformance is not relevant to the complaint condition because cer disruption does not have to do with a disease that the patient has in an adjacent vertebral body.A product investigation was conducted.Exponent incorporated investigation: the device was sent to exponent for external investigation with the following results.All retrieved device components (superior endplate, polyethylene inlay, and inferior endplate) were examined macroscopically for signs of wear and damage.All three components showed evidence of iatrogenic damage.There was no evidence of bone on the backside of the endplates.The superior and inferior endplates had evidence of possible impingement damage.The articulating surface of the inferior endplate had evidence of a biofilm.Machining marks were observed on the backside of the polyethylene inlay.The polyethylene inlay had evidence of discoloration, burnishing, and multidirectional scratching.Manufacturing investigation: the device was also sent to the manufacturing site for investigation with the following results.As received condition: prodisc c, 09.820.046s, lot #7107185 was received with evidence of iatrogenic damage.The superior plate, 09.820.045.2, lot #6918205, the face with laser etch has grind marks extending onto the raised lip around and onto the spherical diameter.Also visible on identified face is bone ingrowth.The peripheral edge has nicks and scratches.The bottom cpti plasma sprayed surface, like top surface and all edges have nicks, scratches and grind marks and visible bone ingrowth inside keel.The inferior plate, 09.820.045.1, lot #6955207 on top face with laser etch has nicks and grind marks extending into the angled recess into inlay pocket.On the bottom cpti plasma sprayed surface are nicks and scratches.Inlay, 09.820.045.4, lot #7143792, has grind marks and melted material on anterior face and spherical radius, also on the anterior edge of spherical radius there is a deep dent/nick.Both slots have visible damage.Also visible from the bottom is the tearing and grinding of the slots.The locking tab is 50% torn and partially missing on the right side.The anterior front face has nicks and deformation.All described nonconformities are post manufacturing.Summary: prodisc-c, 09.820.046s was reviewed for this complaint.The complaint event description did not state any issues or complaints against this prodisc c product; therefore, from a manufacturing perspective, there are no complaints with this product; therefore, there will be no further investigation, complaint is not confirmed.Review of exponent report: prodisc c, 09.820.046s, was reviewed in exponent report.This complaint ¿as received condition¿ was compared to exponent (18082201) report and found similar conditions except, no area of possible impingement was identified during product investigation on superior and inferior plates.Specification: there are no specifications to address, there are no complaints stated against this product.Conclusion: the complaint condition could not be confirmed based on the provided information.However, the overall complaint condition is, conservatively, consider confirmed as evidence of possible impingement was observed on the device components.No product issues or defects were identified and no product design or manufacturing defects or deficiencies were observed during the investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Date of report , date rec¿d by mfr : the incorrect date was inadvertently utilized in initial medwatch.The correct date is 8/20/2018.  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 LARGE 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: 7848033
• Report Number: 2939274-2018-53641
• Device Sequence Number: 19170151
• Product Code: MJO
• UDI-Device Identifier: 10705034763798
• UDI-Public: (01)10705034763798
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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 Expiration Date: 10/31/2015
• Device Model Number: 09.820.046S
• Device Catalogue Number: 09.820.046S
• Device Lot Number: 7107185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention