MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ALIF PEEK 12° 27X36X14MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	8880-5214
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Eczema (4547); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2020-00618 thru 3012447612-2020-00622, and 3012447612-2020-00626.
Event or Problem Description
It was reported that the patient is having a possible allergic reaction to some spinal implants.The installed implants include an epic construct and a breckenridge cage.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report six of seven for this event.
Event or Problem Description
It was reported that the patient is having a possible allergic reaction to some spinal implants.The installed implants include an epic construct and a breckenridge cage.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report six of seven for this event.
Additional Manufacturer Narrative
Component codes, type of investigation, investigation findings, and investigation conclusions.This follow-up report is being submitted to relay additional information.Summary: the complaint is unrefuted for one (1) of one (1) unreturned alif peek 12d 27x36x14mm (pn: 8880-5214) for the failure of patient harm (allergic reaction).The products were not returned, and no photos were provided.Medical records were not provided for review.Potential cause: since the products were not returned and no photos or medical test records were provided, root cause can't be established.Dhr review and related actions: lot numbers were not provided, therefore dhr review can't be performed.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Additional Manufacturer Narrative
H6 additional clinical sign: 4110.Corrections in h6: investigation type, findings, and conclusions device evaluation: the device remains implanted, so a physical examination cannot be performed.A ct scan image was provided which shows the pedicle screw at left l4 is protruding out of the front of the vertebral body.The allergic reaction cannot be confirmed using the provided ct scans and x-ray.Root cause: tests are still being done on the patient to determine the root cause of the allergic reaction.Dhr review: the lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that the patient is having a possible allergic reaction to some spinal implants, including tingling, swelling, and eczema.The installed implants include an epic construct and a breckenridge cage.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report seven of seven for this event.The patient submitted mw5162133.
Additional Manufacturer Narrative
H6 additional clinical sign: 4421.D4 udi number: only the gtin is available since the lot number is unknown.Additional information in a2, a4, a6, b6, b7, and d4: udi number.Corrected information in a5, b5, d2, d3: email, e4, g1, and h6.The patient submitted mw5162133.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that the patient is having a possible allergic reaction to some spinal implants, including tingling, swelling, and eczema.The installed implants include an epic construct and a breckenridge cage.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report seven of seven for this event.The patient submitted mw5162133.

• Brand Name: ALIF PEEK 12° 27X36X14MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035018506
• MDR Report Key: 10713122
• Report Number: 3012447612-2020-00625
• Device Sequence Number: 19703655
• Product Code: MAX
• UDI-Device Identifier: 00888480572886
• UDI-Public: (01)00888480572886
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103666
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2025

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: Other
• Device Catalogue Number: 8880-5214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 03/12/2021; Not provided; Not provided
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 03/17/2021; 01/08/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White