FDA Adverse Event Injury Summary report: N

SCREW

MDR report key: 2820561 · Received October 17, 2012

Report

Report Number: 2520274-2012-02341
Event Type: Injury
Date Received: October 17, 2012
Report Date: October 12, 2012
Product Code: HWC
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

E: ET.AL: MILTON T. M. LITTLE, MD, LIONEL E. LAZARO, MD, RACHEL M. CYMERMAN, BA, DAVID L. HELFET, MD, AND DEAN G. LORICH, MD. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

Description of Event or Problem · 1

A SUBSEQUENT REVIEW OF ARTICLE FROM ORTHOP TRAUMA-VOLUME 26, NUMBER 10, (B)(6) 2012 TITLED: CATASTROPHIC FAILURE AFTER OPEN REDUCTION INTERNAL FIXATION OF FEMORAL NECK FRACTURES WITH A NOVEL LOCKING PLATE IMPLANT BY MARSHALL B BERKES ET. AL. REVEALED THE FOLLOWING; TWENTY-ONE FEMORAL NECK FRACTURES TREATED WITH THE POSTEROLATERAL FEMORAL LOCKING PLATE WERE ELIGIBLE FOR INCLUSION. EIGHTEEN MET INCLUSION/EXCLUSION CRITERIA. SEVEN OF THE 18 CASES EXPERIENCED DEVICE FAILURE. FIVE OF THE 7 PATIENTS REQUIRED TOTAL HIP REPLACEMENT WHEREAS THE REMAINING TWO PATIENTS DIED BEFORE FURTHER TREATMENT. THE REMAINING 11 ACHIEVED BONY UNION. FIVE OF THE 11 PATIENTS EXPERIENCED COMPLICATIONS THAT INCLUDED; A LOCKING SCREW FRACTURE, 2 TOTAL HIP ARTHROPLASTY BECAUSE OF PERSISTENT PAIN, ONE ORIF FOR A SUBTROCHANTERIC FEMUR FRACTURE AT THE LEVEL OF THE DISTAL SCREW AND ONE UNKNOWN COMPLICATION. THIS COMPLAINT IS IN REFERENCE TO THE CASES THAT EXPERIENCED DEVICE FAILURE. NO PATIENT DETAILS PROVIDED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		SCREW	HWC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	SCREW\| PLATE