MAUDE Adverse Event Report: SYNTHES BRANDYWINE PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number 09.820.055S

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient had a prodisc-c implant removed on (b)(6) 2015.It was reported that the patient was originally implanted with the prodisc-c implant on (b)(6) 2013 at levels c6-c7.The patient returned to the doctor on an unknown date because the implant was causing pain when the patient swallowed.The implant was positioned too far posterior.It was also reported that the patient had a bulging disc at c5-c6.As stated previously, revision/explant surgery was performed on (b)(6) 2015.The surgeon who performed the revision was not the surgeon who performed the initial surgery.The surgeon removed the prodisc-c implant without complication.He placed a musculoskeletal transplant foundation (mtf) 7mm cc-acf spacer in the disc space and did an anterior cervical discectomy and fusion (acdf) on cd-6.The surgeon placed a 6mm cc-acf spacer in the cd-c6 disc space.The surgeon placed a 2-level vectra plate over c5-7 and fixated with a 4.0 x 16mm self-drilling variable angle vectra screws.It was reported that the revision surgery was successfully completed without any complications or surgical delay.The superior and inferior endplates of the prodisc-c implant are available for return; however, the poly inlay was accidentally destroyed during the cleaning process.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient initials are (b)(6).Patient weight was not provided by reporter.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Internal review was performed.The investigation of the complaint articles indicates that the: there is no evidence of device failure or malfunction that warrants further actions and no new risks can be identified.There is damage present on the superior and inferior endplates, which is consistent with tool marks and surgical removal technique.There are signs of impingement on the endplates.No new risks, user needs, or updates to the product development evaluation for complaint (b)(4) have been identified as a result of the condition of the device.Exponent analyzed a retrieved total disc replacement provided directly from depuy synthes spine.The accompanying clinical information was supplied directly to exponent by depuy synthes spine.This report was provided to depuy synthes spine for review for accuracy, as such no further action is required.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.

Manufacturer Narrative

(b)(4): subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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 Description

The lot numbers for the two endplates recieved were listed as 6982590 and 6955164.

Manufacturer Narrative

Internal review was performed.The investigation of the complaint articles indicates that the:exponent analysis report (b)(4), a review of exponent analysis report (b)(4) found no additional information or objective evidence indicating that the manufacturing of the reported product is relevant to the complaint condition reported as adverse event:no reported product problem.Both reports indicate post manufacturing iatrogenic damage or impingement to the product during its use and/or explantation.Therefore, the original disposition of unconfirmed, as reported by (b)(4), remains valid.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (part number, 09.820.055s, prodisc-c implant large deep 5mm-sterile, lot number 7099882).The subject device was received with the superior endplate and inferior endplate exhibited damage consistent with implant removal.The polyethylene inlay was not returned.Prodisc-c is a spinal implant intended as a replacement for diseased/ degenerated intervertebral discs of the cervical spine.The prodisc-c total disc replacement procedure involves the removal of a diseased/ degenerated disc, and subsequent restoration of intervertebral disc height and potential for motion via placement of the implant.The complaint description stated that the prodisc-c implant was positioned too far posterior, causing pain for the patient.The prodisc-c implant was removed, and an acdf was performed.The returned superior endplate and inferior endplate exhibited damage consistent with implant removal.The polyethylene inlay was not returned.The condition of the implant did not reveal any design related issues.The prodisc-c design was reviewed.Pain is listed on the prodisc-c package insert as one of the several potential risks associated with this device and in general with the implantation of spinal implants.A definitive root cause for the complaint condition could not be determined.The malposition of the implant could have resulted in pain for the patient.No design related issues were identified with the prodisc-c implant.An exponent evaluation is being performed for the returned subject device components.The results of this evaluation are pending completion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional part lot #6955164.Expiration date: 02/2017.A manufacturing investigation action was conducted/performed.The report indicates that the: part 09.820.055s, lot# 7099882 has been received with post manufacturing damage consisting of scratches and deformation on the top and bottom surfaces.Poly inlay wasn¿t returned.There were no issues identified that pertained to the complaint condition.The visible damage to the part is consistent with the implant and removal of the device.Per the complaint description ¿no reported product problem¿, no issues were found with the device.Therefore, there are no relevant features to evaluate, and no further investigation is required.The disposition of this evaluation is unconfirmed.(b)(4).Device history records was conducted.The report indicates that the dhr for part #09.820.055s, lot 7099882, dhr records for part # 09.820.055s, lot 7099882 indicate that the reported product was manufactured at the (b)(4) manufacturing facility on 04/04/2013 under (b)(4).Dhr records indicate that the product lot was manufactured in accordance with all established requirements with (1) non conformity reported under (b)(4) indicates that the ncr was initiated and the lot placed on hold on 01/02/2013 due to a water leak.All specified rework activities and records indicate that the reworked product underwent all specified rework activities and successfully passed all specified inspection with no additional nonconformities reported.The product was packaged and labeled on 03/21/2015 to indicate an expiration date of 02/2017.There is no objective evidence indicating that the nonconformity reported or resulting rework is relevant to the complaint reported as adverse event, no reported product problem.Dhr records for the reported lot indicate that the product utilized the following synthes sub-components: p/n 09.820.055.1, lot #6982590, p/n 09.820.055.2, lot #6955164, p/n 09.820.055.3, lot #7031144 & 7109928.P/n 09.820.0552, lot#6955164 dhr records for superior plate, size ld, part #09.820.055.2, lot 69155165 indicate that the sub-component product lot was manufactured at the (b)(4) manufacturing facility on 08/16/2012 under (b)(4).Dhr records indicate that the sub-component lot underwent all specified inspection requirement with no product nonconformities reported.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 DEEP 5MM-STERILE
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4882689
• MDR Text Key: 5865253
• Report Number: 2530088-2015-10503
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 09.820.055S
• Device Lot Number: 6982590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention