FDA Adverse Event Injury Summary report: N

TSRH SPINAL SYSTEM

MDR report key: 7235578 · Received February 2, 2018

Report

Report Number: 1030489-2018-00154
Event Type: Injury
Date Received: February 2, 2018
Report Date: February 1, 2018
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWP
PMA / PMN Number: SEE H10
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH IT IS UNKNOWN IF THE PRODUCTS INVOLVED CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PART#: G8293645; LOT#: UNKNOWN; QTY:6; SIMILAR PRODUCT: 8293645; 510K#: K030285; PART#: G8292036; LOT#: UNKNOWN; QTY:6; SIMILAR PRODUCT: 8292036; 510K#: K031967; PART#: UNKNOWN; LOT#: UNKNOWN; QTY:2. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION(PLIF) LEVELS: L3/4/5 IT WAS REPORTED THAT ON AN UNKNOWN DATE,POST -OPERATIVELY, PROXIMAL JUNCTIONAL KYPHOSIS(PJK) OCCURRED AFTER PERFORMING PLIF. THERE WAS NEUROLOGICAL SYMPTOM AT L5. THE FIXATION WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT AND PLIF WAS ADDED AT SINGLE LEVEL (L5/S) WHEREAS THE REVISION SURGERY WAS PERFORMED AT L-1/4. NO PRODUCT MALFUNCTIONS WERE REPORTED. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH THE NEW PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
81321	TSRH SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R