MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGILON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	88861957-32
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a dural repair procedure, while suturing the tissue, the surgeon broke two (2) needles (needle tip) in the patient.The device fell into the patient cavity, an x-ray was used to locate the needle.The device was replaced by another manufacturer's product to complete the case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGILON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8151013
• Report Number: 9612501-2018-02206
• Device Sequence Number: 11205195
• Product Code: GAR
• UDI-Device Identifier: 10884521072749
• UDI-Public: 10884521072749
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K981582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 88861957-32
• Device Catalogue Number: 88861957-32
• Device Lot Number: D8H1714X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: Required Intervention