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

Model Number	09.820.075S
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's direct information indicates a possible allergic response to nickel used in the manufacture of prodisc c.The patient has systemic inflammation as well as pain and local inflammation to the prodisc c.The prodisc c device is believed to be a contributor to the patient's allergic response.The patient also has a previous fusion of c5-7 with a plate and corpectomy cage (all titanium alloy implants) and did not have the rash or inflammation prior to the implant of the prodisc c devices.This information led to a determination the complaint is a reportable event requiring an mdr submission.No other submissions are required.Dhr review did not find any problems in manufacturing which may have contributed to the complaint.Complaint history found the rate of allergy to prodisc implants is improbable/negligible.The rate is within expected limits based on the risk assessment.The prodisc c dfmea identifies allergy to implant materials as a potential risk and patient harm.The device remains implanted and is not planned/ scheduled to be removed.Removal of the prodisc c implants is not planned at this time as the patient's prior neck and arm pain have resolved completely.The prodisc c ifu indicates that allergy to implant materials is a contraindication.The investigation determined the complaint is likely due to a patient - implant biocompatibility.Though rare and improbable likelihood of occurrence, some patients will be allergic to the implant materials.This condition is contraindicated in the device labeling.This situation suggests the allergy was discovered after the patient had already received the prodisc c implants.This submission is for 2 of 2 devices involved in the event.
Event or Problem Description
On (b)(6) 2022 the surgeon scheduled a 2 level pdc, adjacent levels above and below a previous fusion of c5-7.The patient had an existing plate and corpectomy cage (all titanium alloy implants).Before starting the case, the surgeon asked what the nickel content is in the prodisc c.A letter stating 0.18% in co-28cr-6mo cobalt chromium was provided to the surgeon.The patient had a possible nickel allergy, but said it was mostly a skin reaction to some jewelry.Surgeon implanted 2 prodisc c implants per scheduled procedure.Two weeks post op, the patient has been complaining and treated for face neck and upper chest rashes and irritation.Patient was treated with steroids and antibiotics as it thought it may be a possible surgical site infection.Since finishing the course of medication, the irritation, rash and now swelling around the eyes has worsened.Patient had all neck and arm pain and issues resolved completely with the 2 level prodisc c.Patient is doing very well from that aspect.No indication of surgical intervention.

• Brand Name: PRODISC C US IMPLANT EXTRALARGE-DEEP 5MM
• Common Device Name: 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: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 13906428
• Report Number: 3007494564-2022-00013
• Device Sequence Number: 14570322
• Product Code: MJO
• UDI-Device Identifier: 00843193112903
• UDI-Public: 00843193112903
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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: 03/31/2022
• Device Model Number: 09.820.075S
• Device Lot Number: H618108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female