FDA Adverse Event
Injury
Summary report: N
MOUNTIANEER 2.3X4MM SCREW
MDR report key: 1970500
·
Received January 20, 2011
Report
- Report Number
- 1526439-2011-00003
- Event Type
- Injury
- Date Received
- January 20, 2011
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- KWP
- PMA / PMN Number
- K042508
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO CONNECTION THAT CAN BE MADE BETWEEN THE ADVERSE OUTCOME (INFECTION) AND THE DEPUY IMPLANTS USED IN THE CASE. PRODUCTS ARE SUPPLIED NON-STERILE.
Description of Event or Problem · 1
CONTACT REPORTS THAT A PT UNDERWENT A CERVICAL LAMINOPLASTY. SEVENTEEN DAYS LATER, THE PT PRESENTED WITH AN INFECTION AND SURGEON EXPLANTED ALL THE HARDWARE. AS AN ADVERSE OUTCOME WAS REPORTED, AN MDR IS FILED TO DOCUMENT THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOUNTIANEER 2.3X4MM SCREW | SPINAL FIXATION DEVICE | KWP | DEPUY SPINE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) 8MM SIDE BY SIDE PLATE| (B)(4) 8MM INLINE PLATE |