FDA Adverse Event Malfunction Summary report: N

DIAMOND

MDR report key: 11704362 · Received April 21, 2021

Report

Report Number: 3004893332-2021-00003
Event Type: Malfunction
Date Received: April 21, 2021
Date of Event: April 12, 2021
Report Date: April 12, 2021
Manufacturer: SPINAL ELEMENTS, INC
Product Code: KWQ
PMA / PMN Number: K100265
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DHR REVIEW CANNOT BE COMPLETED AT THIS TIME AS THE PRODUCT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS IT WAS HELD BY USER FACILITY AND THEREFORE COULD NOT BE EVALUATED. DURATION OF IMPLANTATION COULD BE A CONTRIBUTING FACTOR. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, PATIENT COMPLIANCE WITH POSTOPERATIVE CARE INSTRUCTIONS, OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT. IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT. ROOT CAUSE OF SPECIFIC FAILURE MODE CANNOT BE DETERMINED.

Description of Event or Problem · 1

APPROXIMATELY SEVEN YEARS AGO, PATIENT UNDERWENT A THREE LEVEL ACDF WITH ANTERIOR CERVICAL PLATE (ACP) C3-C6. REPORTEDLY PATIENT FELT SCREW AGAINST THEIR ESOPHAGUS AND ON (B)(6) 2021, RADIOGRAPHS DEPICTED THE LEFT C3 BONE SCREW ON THE ACP HAD BACKED OUT. ON (B)(6) 2021 REVISION SURGERY WAS PERFORMED TO REMOVE HARDWARE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
601412	DIAMOND	ANTERIOR CERVICAL PLATE SYSTEM	KWQ	SPINAL ELEMENTS, INC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention