MAUDE Adverse Event Report: IMPLANTECH ASSOCIATES, INC. CONTOURFLEX(TM) CALF IMPLANTE TEXTURED (CARLSEN STYLE); CONTOURED CARVING BLOCK

Model Number	N/A
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: testing was performed on actual devices associated with this report.Implantech reviewed production/manufacturing records.Results: evaluation found no device problem.(device complied with specifications.) conclusion: no problem was detected.
Event or Problem Description
(this is the same patient and same event being reported in medwatch report # 2028924-2018-00007.) complainant reported that the dimensions of the implants did not match those that we have listed.The initial report indicated that the patient had been put under anesthesia, and they had to wake her up without doing the surgery due to their concerns regarding the dimensions.Subsequent follow-up revealed that the patient had other surgical procedures performed on that date, and that the intended surgery to implant the "subject" devices was not the sole reason why the patient was placed under anesthesia.No subsequent intervention has been reported.Though there is no clear information that the reported event necessarily constitutes a serious injury, implantech has elected to report this event in the abundance of caution.(the event date will be considered to be (b)(6) 2018, the date of the surgery in which "subject" devices were not implanted due to the concerns reported above.).

• Brand Name: CONTOURFLEX(TM) CALF IMPLANTE TEXTURED (CARLSEN STYLE)
• Common Device Name: CONTOURED CARVING BLOCK
• Manufacturer (Section D): IMPLANTECH ASSOCIATES, INC.; 6025 nicolle street, suite b; ventura CA 93003
• MDR Report Key: 8081377
• Report Number: 2028924-2018-00008
• Device Sequence Number: 1203573
• Product Code: MIB
• UDI-Device Identifier: M724CCB7TC3L1
• UDI-Public: M724CCB7TC3L1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K982688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: 07/20/2023
• Device Model Number: N/A
• Device Catalogue Number: CCB7-T0C#L
• Device Lot Number: 878746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/16/2018
• 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: Other
• Patient Age: 34 YR