FDA Adverse Event
Malfunction
Summary report: N
ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM
MDR report key: 1767244
·
Received July 17, 2010
Report
- Report Number
- 3005673311-2010-00006
- Event Type
- Malfunction
- Date Received
- July 17, 2010
- Date of Event
- June 5, 2010
- Report Date
- July 16, 2010
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- KWQ
- PMA / PMN Number
- K050813
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT, DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR EVALUATION. IN ADDITION, AESCULAP IMPLANT SYSTEMS HAS REQUESTED PT X-RAYS TO REVIEW AND AIDE IN OUR INVESTIGATION OF THE INCIDENT.
Description of Event or Problem · 1
ORIGINAL SURGERY DATE: (B)(6) 2010. TYPE OF SURGERY (ORIGINAL): ACDF. REASON FOR REVISION: 2 SCREWS BACKING OUT OF BOTTOM OF PLATE. NO INJURY OR DEATH. SURGERY WAS NOT PROLONGED, HOWEVER, A REVISION SURGERY WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM | KWQ | AESCULAP AG & CO. KG | FJ933T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |