FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE EXTENSION
MDR report key: 3020087
·
Received March 25, 2013
Report
- Report Number
- 6000153-2013-00046
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Date of Event
- March 7, 2013
- Report Date
- June 1, 2022
- Manufacturer
- NEURO - VILLALBA
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS OF THE OBTURATOR FOUND THAT IT WAS BROKEN AT THE INJECTION MOLD GATE. SMALL CRACKS WERE OBSERVED WITHIN THE MATERIAL AT THE GATE. INJECTION MOLD GATES WITH NON-UNIFORM SURFACES ARE MORE LIKELY TO FAIL WHEN BENDING.
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_TUNNELINGTOOL, PRODUCT TYPE ACCESSORY. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TUNNELING DEVICE ON ONE OF THE EXTENSIONS BROKE WHILE TUNNELING. A PIECE OF THE OBTURATOR THAT FITS IN THE TUNNELING TOOL ACTUALLY BROKE OFF AND A PIECE GOT STUCK IN THE TUNNELING TOOL. A DIFFERENT TUNNELING TOOL WAS USED WHICH WORKED FINE. THE REPORTER INDICATED THAT THE PATIENT WAS FINE AND THE OUTCOME WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121986 | IMPLANTABLE EXTENSION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | NEURO - VILLALBA | 37082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | "SEE H10...." |