FDA Adverse Event Injury Summary report: N

VERTEX RECONSTRUCTION SYSTEM

MDR report key: 7177650 · Received January 10, 2018

Report

Report Number: 1030489-2018-00036
Event Type: Injury
Date Received: January 10, 2018
Date of Event: April 1, 2016
Report Date: March 13, 2018
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWP
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART# 7750088, LOT# UNK, 510K: K070742, UDI# (B)(4), QUANTITY: 1. PART# 6950315, LOT# UNK, 510K: K052180, UDI# (B)(4), QUANTITY: 6. PART# 6958724, LOT# UNK, 510K: K083071, UDI# (B)(4), QUANTITY: 1. PART# 6958726, LOT# UNK, 510K: K083071, UDI# (B)(4), QUANTITY: 1. PART# 6958734, LOT# UNK, 510K: K083071, UDI# (B)(4), QUANTITY: 3. PART# 6958736, LOT# UNK, 510K: K083071, UDI# (B)(4), QUANTITY: 1. ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

Description of Event or Problem · 1

PATIENT UNDERWENT POSTERIOR DECOMPRESSION WITH FUSION.

Description of Event or Problem · 1

IT WAS REPORTED THAT IN (B)(6) 2016, POST-OP, PATIENT WAS EXPERIENCING A LOT OF PAIN IN THE AREA WERE THE DEVICE WAS IMPLANTED. SURGEON FOUND NOTHING CONCERNING IMPLANTS; HOWEVER, PAIN WAS STILL PRESENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
21588	VERTEX RECONSTRUCTION SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Other