LOCKING SCREW ANCHORAGE Ø3.0MM / L14MM

Report

Report Number: 0008031020-2016-00365
Event Type: Injury
Date Received: July 29, 2016
Date of Event: August 5, 2015
Report Date: December 29, 2016
Manufacturer: STRYKER GMBH
Product Code: HRS
PMA / PMN Number: K083447
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 1

THIS DEVICE IS CONCOMITANT AND DID NOT CONTRIBUTE TO THE REPORTED FAILURE. IF ANY ADDITIONAL INFORMATION IS PROVIDED INDICATING OTHERWISE THE RECORD WILL BE REOPENED AND THE INVESTIGATION WILL BE REWORKED.

Description of Event or Problem · 1

IT WAS REPORTED VIA FDA MAUDE REPORT MW 5062947, HAD SURGERY, ARTHRODESIS AND FUSION SINGLE JOINT RIGHT TOE (1ST MTP FUSION). ALSO HAD EXCISION OF NEUROMA 2ND INNERSPACE RIGHT FOOT AT THE SAME TIME. THE FUSION NEVER HAPPENED, JUST HAD 2ND SURGERY WITH BONE GRAFT, SECOND SURGEON FOUND THE ORIGINAL PLATE BROKEN AND SCREWS LOOSE, WAS SENT TO PATHOLOGIST.

Description of Event or Problem · 1

IT WAS REPORTED VIA FDA MAUDE REPORT MW 5062947, HAD SURGERY, ARTHRODESIS AND FUSION SINGLE JOINT RIGHT TOE (1ST MTP FUSION). ALSO HAD EXCISION OF NEUROMA 2ND INNERSPACE RIGHT FOOT AT THE SAME TIME. THE FUSION NEVER HAPPENED, JUST HAD 2ND SURGERY WITH BONE GRAFT, SECOND SURGEON FOUND THE ORIGINAL PLATE BROKEN AND SCREWS LOOSE, WAS SENT TO PATHOLOGIST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
485212	LOCKING SCREW ANCHORAGE Ø3.0MM / L14MM	PLATE, FIXATION, BONE	HRS	STRYKER GMBH		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention