FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 9893278 · Received March 28, 2020

Report

Report Number: 1030489-2020-00391
Event Type: Injury
Date Received: March 28, 2020
Date of Event: March 6, 2020
Report Date: March 28, 2020
Manufacturer: WARSAW ORTHOPEDICS
Product Code: NKB
PMA / PMN Number: SEE H10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

OTHER: TRANSVERSE PROCESS FRACTURE. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5541113, 510K # K132471 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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 PRESENTED WITH KYPHOSIS; AND UNDERWENT THORACO-LUMBAR VERTEBRAL POSTERIOR FIXATION. IN THIS SURGERY, THE PEDICLES WERE THIN, AND THE PLAN WAS TO PLACE TRANSVERSE PROCESS HOOKS (WIDE BLADE HOOKS) AT T4 AND T5. THE MEDIUM SIZED HOOKS WERE CHOSEN BY TRIAL. WHEN THE ACTUAL HOOKS WERE PLACED AT T5, THE TRANSVERSE PROCESS ON BOTH SIDES FRACTURED; AND THE HOOKS COULD NO LONGER BE PLACED. AS HOOKS WERE ALREADY PLACED AT T4, HOOK PLACEMENT AT T5 WAS SKIPPED. THIS HAD NO IMPACT ON THE OPERATION, WHICH WAS COMPLETED SUCCESSFULLY. NO OTHER PATIENT COMPLICATIONS WERE REPORTED OTHER THAN TRANSVERSE PROCESSES FRACTURE AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357942	CD HORIZON SPINAL SYSTEM		NKB	WARSAW ORTHOPEDICS	NA	0475944W

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other