FDA Adverse Event Injury Summary report: N

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 6375362 · Received March 3, 2017

Report

Report Number: 1030489-2017-00449
Event Type: Injury
Date Received: March 3, 2017
Date of Event: February 6, 2017
Report Date: February 6, 2017
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: KWP
PMA / PMN Number: REFER H10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G6860014 / LOT: UNK (X4) ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 6860014 AND 510K# K992110 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE US. (B)(4). 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENTS (OPLL). FOR WHICH PATIENT UNDERWENT, ANTERIOR CERVICAL DECOMPRESSION FUSION AT LEVELS C4-6. REPORTEDLY, ON (B)(6) 2017, POST-OP, THE PLACED SPINAL PLATE AND SCREW BACKED OUT. THE SCREWS WERE INSERTED IN C4 AND C6. QUANTITY OF SCREW(S) WHICH BACKED OUT IS UNKNOWN. REVISION SURGERY IS SCHEDULED ON (B)(6) 2017.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
159203	PREMIER® ANTERIOR CERVICAL PLATE SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MDT SOFAMOR DANEK PUERTO RICO MFG	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention