MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. COUNTOURFLEX(TM) CALF IMPLANT TEXTURED (CARLSEN STYLE)

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect-clinical code: failure of implant health effect-impact code: surgical intervention investigation-type: actual device was evaluated, production records were reviewed and trend analysis performed.Investigation-findings: though breakage was confirmed, evidence of damage characteristic of sharp instrument was identified (usage problem) investigation-conclusions: product labeling warn that explant surgery may be indicated at any time, and that care should be taken to avoid damage to the implant with sharp instruments.Findings suggest that unintended use error (sharp instrument damage) may have contributed to reported breakage, however exact cause has not been established.
Event or Problem Description
Complainant reported that patient had calf implant explanted more than seven years post-operatively due to it being broken into pieces.The device was replaced with another calf implant.

• Brand Name: COUNTOURFLEX(TM) CALF IMPLANT TEXTURED (CARLSEN STYLE)
• Common Device Name: CALF IMPLANT
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• Manufacturer (Section G): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• Manufacturer Contact: craig arthur ; 6025 nicolle street, suite b; ventura, CA 93003 ; 8053399415
• MDR Report Key: 20604283
• Report Number: 2028924-2024-00001
• Device Sequence Number: 15302109
• Product Code: MIB
• UDI-Device Identifier: M724CCB7TC1L1
• UDI-Public: +M724CCB7TC1L1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K982688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted 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): 11/04/2024

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: 05/10/2020
• Device Model Number: N/A
• Device Catalogue Number: CCB7-T-C1L
• Device Lot Number: 872738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2017
• 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: CCB7-T-C2L (CALF IMPLANT)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male