MAUDE Adverse Event Report: CERAPEDICS I-FACTOR PUTTY; FILLER, BONE VOID, SYNTHETIC PEPTIDE

Model Number	700-010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record the device history record was reviewed for lot 23c1770.One ncr is associated with the foil pouch lot used, ncr 986.However, the ncr is only related to the foil pouch and had no impact on the finished product.There have been no other complaints reported for lot 23c1770.Capas and ncrs associated with lot ncr 986 was associated with the foil pouch lot used.Bubbles were observed in the foil pouch.Pouches were sorted after sterilization and impacted pouches were segregated for qc testing or scrap.This ncr had no impact on the finished product.Risk analysis and previous complaints (b)(4) risk analysis document ra-001, revision 23 (putty) was reviewed.The failure mode identified in this complaint is already identified under line item 40 - "wound complications including hematoma, site drainage, and infection." therefore, no updates to the risk assessment are required.There have been 4 (four) previous complaints related to this potential failure mode.Based on the total number of units distributed (n=286,101), the observed rate is (b)(4).The mitigated risk probability for this potential failure mode is estimated to be 2 or an estimated occurrence rate of (b)(4).Therefore, the benefit-risk analysis remains unchanged.Us putty ifu (p/n 40002-07-4) lists the following as a potential adverse event: "wound complications including hematoma, site drainage, infection dehiscence and/or necrosis".As such, no updates are required for the ifu.Conclusion based on the information available, a causal link between the putty product and the seroma cannot be established.However, out of an abundance of caution this complaint is being incorporated into the risk management process.As listed in the ifu (p/n 40002-07-4), wound complication is listed as a potential adverse effect; therefore, no additional actions are required.
Event or Problem Description
On thursday, 25 april 2024, ea received the following email from (b)(6), ((b)(6) employee): "emily: i trust you are well.I received a call from my distributor that works with dr.(b)(6) in lake charles.He has some concerns based on recent operative outcomes "involving ifactor" he'd like to discuss this with someone tomorrow and is available tomorrow 10:30 central standard time.Please let me know if you are able to connect with him so i can make him aware.Thank you in advance.Cheers, (b)(6) regional sales manager-southeast" ea called dr.(b)(6) on friday, 26 april 2024 as requested, but was not able to connect with surgeon.Additional information received on 13 may 2024: on 13 may 2024, ea received the following email from dr.(b)(6) "hi emily, 1.Product information: part number and lot number | product #: 700-010 | lot #: 23c1770 2.Date of event | wednesday, 04/24/2024 3.Date of initial surgery | dos: (b)(6) 2024 4.Globus medical colonial cage, globus medical resonate plate with screws 5.Patient developed significant pre vertebral edema which dysphagia 6.Patient required return to surgery for washout of pre vertebral space and placement of drain.Please call me at (b)(6) (cell) if you require additional details.Thanks, erich".

• Brand Name: I-FACTOR PUTTY
• Common Device Name: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): CERAPEDICS; 11025 dover street; suite #1600; westminster CO 80021
• Manufacturer Contact: emily aulby ; 11025 dover street; suite #1600; westminster, CO 80021
• MDR Report Key: 19492703
• Report Number: 3007155473-2024-24173
• Device Sequence Number: 7089598
• Product Code: NOX
• UDI-Device Identifier: 00850001680004
• UDI-Public: (01)00850001680004(17)260630(1023C1770
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: 06/30/2026
• Device Model Number: 700-010
• Device Lot Number: 23C1770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GLOBUS MEDICAL COLONIAL CAGE; GLOBUS MEDICAL RESONATE PLATE WITH SCREWS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown