MAUDE Adverse Event Report: SKELETAL KINETICS CRANIOSCULPT FLOW, 5CC; BONE VOID FILLER

Catalog Number C-FLOW5CC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

The craniosculpt, flow, 5cc, p/n c-flow5cc, was not returned to osteomed.According to the complaint, the "patient was taken to the or for wound wash out and cement removal.Patient was given antibiotics for infection as drainage from wound was observed".Questions regarding the infection were sent to the surgeon, and answers were received.The surgeon could not pinpoint the source of the infection, but did not attribute it to the craniosculpt implant.The only possibility brought forward was that the "patient was using fingers poking and picking at incision" which might have contributed to the infection.The reason for the infection could not be determined.Review of the dhr identified a non-conformance; that involved an over labeling effort in order to change from the (b)(6) address to the new (b)(6) address.A two-year review did not identify any capas related to this implant.A two-year review of the ncr database found two unrelated events, both involving labeling issues.This is the only complaint for this issue, "post-op infection (not attributed to implant)", discovered in a two-year review of the complaint database for craniosculpt flow implants.The craniosculpt, flow, 5cc, p/n c-flow5cc, is a part of the sk family of products.The calcium phosphate (cap) impactable and injectable design failure modes and effects analysis (dfmea), covers the risk of an infection due to a non-sterile device is covered in the dfmea.This risk has a rating of 3, which per the sk risk analysis, procedure is "critical" (potential of death or serious injury).The likelihood has a value of 2, which per the procedure is "unlikely" (between one in a million and one in ten thousand).This gives a final risk rating of 6, which is "acceptable" per procedure.The craniosculpt flow instructions for use (ifu) lists contraindications such a use in an infected site, in patients with an abnormal calcium metabolism, metabolic bone disease, a recent untreated infection or immunological abnormalities.The ifu warns surgeons not to use the product in patients with an infection during the last three months.Finally, the ifu states, "sterile product packaging should be inspected for flaws and integrity prior to opening.In the presence of such a flaw, the product must be considered non-sterile and appropriately discarded." this issue will be monitored through routine trending.

Event Description

Per the customer it was reported that a patient was taken to the operating room for wound wash out and cement removal.Patient was given antibiotics for infection as drainage from wound was observed.The original procedure was for acoustic neuroma on (b)(6) 2019.The doctor noted that the patient was using fingers poking and picking at incision multiple times during follow up exams.The doctor recommended the patient to take benadryl as the patient complained of itching.

• Brand Name: CRANIOSCULPT FLOW, 5CC
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): SKELETAL KINETICS; 3885 arapaho road; addison, tx
• Manufacturer (Section G): SKELETAL KINETICS; 3885 arapaho road; addison, tx
• Manufacturer Contact: flor rivera ; 3885 arapaho road; addison, tx
• MDR Report Key: 9701797
• MDR Text Key: 192411490
• Report Number: 2027754-2020-00001
• Device Sequence Number: 1
• Product Code: PJM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: C-FLOW5CC
• Device Lot Number: 1129763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR