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

Model Number	09.820.035S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Event date: unknown when irritation began.Explant date: not explanted.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.Investigation summary: 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.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 is experiencing a possible delayed hypersensitivity reaction with "bizarre symptoms." she underwent a c5-c6 artificial disc replacement with pro disc-c artificial disk ( 15 mm wide x 14 mm deep x 5mm height) on (b)(6) 2016.The patient is seeking materials composition for the implant, as she has been referred by the surgeon for patch testing for a possible delayed hypersensitivity reaction.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part no: 09.820.035s, lot no: 7943931: supplier dhr: n/a: manufacturing location: (b)(4).Released by: (b)(4), manufacturing date: 27-mar-2015, expiration date: 28-feb-2019: part #: 09.820.035s, lot#: 7943931 (sterile) ¿ prodisc-c implant medium deep 5mm - sterile.Quantity 30: no non-conformance 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 condition.Sterility documentation was reviewed and determined to be conforming.Part/lot are shipped and vendor sterilized.Date of event reported inadvertently on initial medwatch report; however date of postoperative allergic reaction development is unknown.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 5MM-STERILE
• Common Device Name: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester 19380
• MDR Report Key: 7253442
• Report Number: 2939274-2018-50564
• Device Sequence Number: 19077662
• Product Code: MJO
• UDI-Device Identifier: 10705034763750
• UDI-Public: (01)10705034763750(17)190228(10)7943931
• Combination Product (Y/N): N
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 02/28/2019
• Device Model Number: 09.820.035S
• Device Catalogue Number: 09.820.035S
• Device Lot Number: 7943931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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
• Patient Age: 35 YR