FDA Adverse Event Malfunction Summary report: N

OVERWATCH

MDR report key: 12619060 · Received October 12, 2021

Report

Report Number: 3004893332-2021-00014
Event Type: Malfunction
Date Received: October 12, 2021
Date of Event: October 4, 2021
Report Date: October 12, 2021
Manufacturer: SPINAL ELEMENTS, INC
Product Code: LXH
UDI-DI: 00840916134686
PMA / PMN Number: K161842
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

DURING THE REVIEW OF DHR, IT WAS CONCLUDED THAT THE PRODUCT WAS INSPECTED AND ACCEPTED FOR USE AND MET ALL SPECIFIED PARAMETERS OF THE QUALITY INSPECTION PROCESS (QIP) WITH NO ASSOCIATED NONCONFORMANCE SPECIFIC TO THIS PRODUCT ISSUE. RETURNED DEVICE WAS VISUALLY INSPECTED, FUNCTIONALLY TESTED AND THE COMPLAINT WAS CONFIRMED. THE DEVICE TIP IS FRACTURE OFF. THE DEVICE OTHERWISE MEETS DIMENSIONAL SPECIFICATIONS, EXCEPT FOR THE FRACTURED TIP. ROOT CAUSE IS UNKNOWN, BUT OSTEOSCLEROTIC BONE AND/OR EXCESSIVE FORCE CAN RESULT IN DEVICE TIP FRACTURING.

Description of Event or Problem · 0

WHILE DRIVING THE PEDICLE BONE SCREW, REPORTEDLY THE DRIVER TIP FRACTURED AND REMAINED IN THE HEAD OF THE SCREW SHANK. THOUGH THE DRIVER TIP WAS IDENTIFIED, THE SURGEON ELECTED TO LEAVE THE DRIVER TIP AND THE SCREW IN PLACE. NO INJURY TO THE PATIENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1514402	OVERWATCH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	LXH	SPINAL ELEMENTS, INC	108-107-01-S	211293	00840916134686

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR