BARRICAID ACD
Report
- Report Number
- 3006232063-2022-00037
- Event Type
- Injury
- Date Received
- November 10, 2022
- Date of Event
- January 22, 2022
- Report Date
- December 22, 2022
- Manufacturer
- INTRINSIC THERAPEUTICS, INC
- Product Code
- QES
- UDI-DI
- M906BARA810MM0
- PMA / PMN Number
- P160050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMPLANT WAS OBSERVED TO BE IN ORIGINAL POSITION DURING SURGERY. SCAR TISSUE WAS IDENTIFIED BY THE SURGEON WHICH LIKELY CONTRIBUTED TO THE LEG PAIN THE PATIENT WAS EXPERIENCING. THE MESH WAS REMOVED DURING SURGERY BUT THE TITANIUM ANCHOR REMAINED IMPLANTED. A TLIF WAS PERFORMED BY THE SURGEON IMPLANT MESH WAS RETRIEVED AND SENT TO A 3RD PARTY LABORATORY FOR EVALUATION PER PAS002 "EXPONENT PRO.214, INTRINSIC BARRICAID RETRIEVAL PROTOCOL" RESULTS OF PAS ARE SUBMITTED ANNUALLY.
INTRINSIC BECAME AWARE OF A PRIOR SURGERY WHILE INVESTIGATING (B)(4) AND ON 06-DEC-2022 THE SURGEON PROVIDED US THE DETAILS. THE DEVICE WAS NOT BELIEVED TO BE INVOLVED SINCE THE SURGEON LEFT IT IMPLANTED. THIS ALL OCCURRED BEFORE WE BECAME AWARE OF (B)(4) INITIAL CASE DETAILS.
PATIENT UNDERWENT A REVISION SURGERY THAT CONSISTED OF: MESH REMOVAL WITH TLIF. INDICATIONS: LEG PAIN. SCAR TISSUE WHICH WAS NOT DUE TO IMPLANT WAS IDENTIFIED UPON DECOMPRESSION, NO HNP, IMPLANT IN ORIGINAL POSITION. BMI AT TIME OF RE-OP WAS 45.27.
PATIENT HAD A HERNIATION AFTER INITIAL BARRICAID IMPLANTATION. THERE WAS A REVISION SURGERY ON (B)(6) 2022 TO RESECT HNP AND LEFT BARRICAID DEVICE IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1911392 | BARRICAID ACD | BARRICAID | QES | INTRINSIC THERAPEUTICS, INC | BAR-A8-10MM | 07212002 | M906BARA810MM0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Male | Required Intervention |