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Catalog Number 51402
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Swelling (2091)
Event Date 10/21/2016
Event Type  malfunction  
Manufacturer Narrative
This report is being filed to correct the product code. Investigation is in process. A follow-up report will be provided.
Manufacturer Narrative
This report is being filed to provide additional information and corrected information. Investigation: the customer stated that they treated a total of 6 patients with prp collected from the reported production lot number, however, of the 6 patients treated, a total of 3 patients had infections post procedure. There have been no other reports of patient infection complaints against this production lot number. Three years of data was reviewed and no other occurrences of patient infection with harvest disposables were identified. A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue. The sterilization process ran as expected and there were no non-conformances or observations. The disposable set was not available for return. However, the customer returned the remaining procedure pack back for investigation. The customer returned 2 unused platelet rich plasma procedure pack and an unused applicator. The expiration dates on the set was 2017-09-01 and none of the associated components had expiry dates prior to the set expiration. The applicator that was returned expired on 2017-06-01. This is prior to the procedure date, but the customer did not indicate that this was the lot of applicators that was used to perform this procedure. No other observations or abnormalities were noted in the returned product. Based on the sterility assurance system employed at terumo bct, the disposable device is not a likely source of the contamination. Potential sources for the contamination are improper aseptic technique and the aspirate coming in contact with non-sterile fluids. Per terumo bct's internal documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of =
10-6. Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every lot of product manufactured. When blood product becomes contaminated following collection, and separation using a terumo bct terminally sterilized device, it is highly unlikely the source of the bacteria was the disposable used to the collect and separate the blood product. Due to the nature of collection blood from humans, contamination will occur at some frequency. Based on the journal article complication rate in 200 consecutive sinus lift procedures: guidelines for prevention and treatment, the most frequent post operative complication for asinus lift procedure was wound infections, which occurred in 7. 1% of the patients having a post-operative infection. Root cause: a definitive root cause could not be determined. Possible causes include but are not limited to:- improper aseptic technique and/or skin preparation- aspirate contacted non-steril fluids. Citation: moreno vazquez, j. C. , gonzalez de rivera, a. S. , gil, h. S. , & mifsut, r. S. (2014). Complication rate in 200 consecutive sinus lift procedures: guidelines for prevention and treatment. Journal of oral and maxillofacial surgery, 72(5), 892-901. Doi:10. 1016/j. Joms. 2013. 11. 023.
Manufacturer Narrative
Additional product code: fmf investigation: per the customer, the patient was given antibiotics prophetically prior to surgery. During the procedure, blood was collected and processed, then administered to the patient without issue. Investigation is in process. A follow-up report will be provided.
Event Description
The customer called to report that a patient underwent a dental implant surgery on (b)(6) 2016 and was treated with platelet rich plasma (prp) product. Approximately one week post procedure, the patient developed painful swelling, exudate and redness in the jaw close to the implant. The patient re-visited the physician at the customer's site. Per physician's order, the patient was given oral antibiotics for several weeks and was released from physician care. The customer reports that the patient is improving and in healthy condition. The customer declined to provide patient's weight.
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Manufacturer (Section D)
lakewood CO 80215
Manufacturer Contact
steve kern
10810 w. collins ave
lakewood, CO 80215
MDR Report Key6788706
MDR Text Key165267961
Report Number1722028-2017-00321
Device Sequence Number0
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/11/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2017
Device Catalogue Number51402
Device Lot Number09Z9940
Other Device ID Number05020583514027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/11/2017 Patient Sequence Number: 1