FDA Adverse Event
Malfunction
Summary report: N
LIFE SPINE
MDR report key: 7470443
·
Received April 27, 2018
Report
- Report Number
- 3004499989-2018-00004
- Event Type
- Malfunction
- Date Received
- April 27, 2018
- Date of Event
- March 26, 2018
- Manufacturer
- LIFE SPINE
- Product Code
- OVD
- PMA / PMN Number
- K091301
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE AWL WAS BEING MALLETING INTO THE SACRUM DURING THE SURGERY. THE TIP OF THE AWL BROKE OFF AND IS IMBEDDED INTO THE PATIENTS SACRUM. THE FRACTURE OF THE AWL WAS CAUSED BY EXCESSIVE FORCE AND THE SCRATCH PATTERN ON THE INSTRUMENT INDICATES THAT THE AWL WAS NOT INSERTED STRAIGHT BUT ON ANGLE WHICH CAUSED TOO MUCH FORCE ON THE TIP.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN AWL WAS BEING STRUCK WITH A MALLET THROUGH THE PRODUCT INSERTED ON THE LEFT MEDIAL INFERIOR SCREW HOLE. UPON MALLETING INTO THE SACRUM, THE TIP BROKE OFF THE INSERTER INTO THE SACRUM. THE STRAIGHT AWL TIP BROKE OFF INTO THE SACRUM. THE TIP WAS UNABLE TO BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312350 | LIFE SPINE | AWL | OVD | LIFE SPINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |