FDA Adverse Event Injury Summary report: N

CLYDESDALE PTC SPINAL SYSTEM

MDR report key: 9202396 · Received October 17, 2019

Report

Report Number: 1030489-2019-01169
Event Type: Injury
Date Received: October 17, 2019
Report Date: October 17, 2019
Manufacturer: MSD DEGGENDORF MFG
Product Code: MAX
PMA / PMN Number: K133205
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# 4922250; LOT# 46BH; 510K# K133205; UDI# (B)(4); QTY# 1 PART# 4986050; LOT# 59CW; 510K# K133205; UDI# (B)(4); QTY: 2. ALTHOUGH IT IS UNKNOWN WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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

IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF CAGE AT L4/5, ILIAC GRAFTING AT L4/5+POSTERIOR FUSION FOR EXTENDING TO SACRAL REGION DUE TO BONE UNION FAILURE. POST-OP, BONE UNION FAILURE WAS REPORTED AT L4-L5. INSTABILITY DUE TO BONE UNION FAILURE WAS ALSO REPORTED. HENCE A REVISION SURGERY WAS PERFORMED, IN WHICH THE CAGE WAS COMPLETELY REMOVED AND ILIAC GRAFTING WAS PERFORMED. ON (B)(6) 2019, FUSION FOR EXTENDING WAS PERFORMED TO SACRAL REGION ON THE POSTERIOR SIDE. PATIENT WAS HOSPITALIZED BECAUSE BONE UNION WAS NOT COMPLETED. THE SURGEON DID NOT KNOW THE CLEAR REASON FOR BONE UNION FAILURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
996056	CLYDESDALE PTC SPINAL SYSTEM	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR	MAX	MSD DEGGENDORF MFG	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R