MAUDE Adverse Event Report: GS MEDICAL CO., LTD. ANYPLUS; ANYPLUS T-PLIF PEEK LUMBAR CAGE

Model Number 1108-0010

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Spinal Column Injury (2081); Tingling (2171); Foreign Body In Patient (2687)

Event Date 03/05/2015

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided so dhr review could not be conducted.The complaint sample was not for investigation.From product from inventory impact testing was conducted to confirm the strength of the impact meet specification, which it was confirmed.The complaint investigation could not be completed due to insufficient information provided by the user account.Internal testing confirm inventory product meet specifications.

Event Description

According to the distributor: our bn plif implant "exploded" into two pieces during insertion.A portion of the implant moved medially and posteriorly wedging itself into the canal creating a dural tear on the anterior side of dura.Dr.(b)(6) was successful in explanting both peices and repairing the dural tear however the patient is still in the hospital as of (b)(6) 2015 due to dural tear as well as now experiencing paraethesia on the left side/ leg.Note: patient initially presented with right side/ leg symptoms prior to surgery.

• Brand Name: ANYPLUS
• Type of Device: ANYPLUS T-PLIF PEEK LUMBAR CAGE
• Manufacturer (Section D): GS MEDICAL CO., LTD.; 90, osongsaengmyeong 4-ro, oso; heungdeok-gu; cheongju-si, chungcheonbuk 28161 ; KS 28161
• Manufacturer Contact: young-sik park ; 90, osongsaengmyeong 4-ro, oso; heungdeok-gu; cheongju-si, chungcheonbug 28161 ; KS 28161 ; 0432377393
• MDR Report Key: 6153762
• MDR Text Key: 62468202
• Report Number: 3005596514-2015-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1108-0010
• Device Catalogue Number: 25X10X0
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• 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