MAUDE Adverse Event Report: AUGMENIX, INC SPACEOAR SYSTEM; HYDROGEL SPACER

Catalog Number SO-2101

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

Augmenix medical consultant reviewed mr images with complainant physician on april 14, 2017.Complainant physician stated patient has a pretty high risk disease.He got a cs seed implant with spaceoar placement at time of implant four weeks ago.Complainant physician said imaging showed good spaceoar placement and rectal separation.No perineal pressure or pain but super painful rectal exam and very painful with each bowel transit.No fevers or elevated wbc.Treating physician started him on cipro and flagyl.Patient is slightly getting better but he doesn't think its from abx.Gas on cbct is main reason he is thinking infection.In follow-up with complainant physician, he had informed us that patient pain has gotten better with antibiotics.Patient had completed treatment and returned to work.At last cbct air was still present and not obviously different.Sterilization records were reviewed and were within specifications.No additional infection complaints were received associated with this production lot of (b)(4) units released for distribution august 19, 2016.

Event Description

Complainant physician notified augmenix, inc.That patient who had a space oar and seed implant was experiencing rectal pain and there is also unusual air in space.Complainant physician is worried about infection and would like to speak with someone about it.

• Brand Name: SPACEOAR SYSTEM
• Type of Device: HYDROGEL SPACER
• Manufacturer (Section D): AUGMENIX, INC; 204 second avenue; waltham MA 02451
• Manufacturer (Section G): AUGMENIX,INC; 204 second avenue; waltham MA 02451
• Manufacturer Contact: james mayol ; 204 second avenue; waltham 02451 ; 7819021665
• MDR Report Key: 6567901
• MDR Text Key: 75189997
• Report Number: 3008550999-2017-00002
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: (01)00864661000102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN140030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2018
• Device Catalogue Number: SO-2101
• Device Lot Number: 11071601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 80