PASS LP

Report

Report Number: 1000432246-2012-00001
Event Type: Injury
Date Received: April 5, 2012
Date of Event: January 23, 2012
Report Date: April 3, 2012
Manufacturer: MEDICREA INTERNATIONAL
Product Code: MNI
PMA / PMN Number: K080099
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION: REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION COULD NOT LEAD TO DEFINE THE PRECISE ROOT CAUSE OF THIS ADVERSE EVENT. CONCLUSION: THIS EVENT SEEMS TO BE POSSIBLY RELATED TO SURGERY BUT NOT RELATED TO THE DEVICE. IMPLANTS USED IN SURGERY INCLUDED: 510(K) K080099; B02130005: NUT; B02214530: POLYAXIAL SCREW 04.5MM, LENGTH 30MM; B02215535: POLYAXIAL SCREW 05.5MM, LENGTH 35MM; B02215540: POLYAXIAL SCREW 05.5MM, LENGTH 40MM; B02215530: POLYAXIAL SCREW 05.5MM, LENGTH 30MM; B02126020: ROD 06.0, LENGTH 200MM; 510(K) K082577; B99100210: DEROTATION CONNECTOR; 510(K) K082069; B02240106: POLYAXIAL PEDICULAR HOOK.

Description of Event or Problem · 1

PATIENT HAD A SPINE FUSION (T4-T12) ON (B)(6) 2012. SHE WAS ADMITTED TO HOSPITAL (B)(6) BECAUSE OF COMPLAINTS OF ABDOMINAL PAIN, DIZZINESS, SYNCOPE, LOOSE BLACK STOOLS, VOMITING DARK COFFEE GROUNDS AND ANEMIA FOR THE LAST 24 HOURS. SHE WAS DISCHARGED ON (B)(6) WITH MEDICATIONS. ON (B)(6), PATIENT WAS ADMITTED TO THE HOSPITAL. ALL CULTURES AND BLOOD TESTS WERE REVIEWED TO BE NORMAL AND THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6), AT 6 WEEK POST OPERATIVE FOLLOW-UP, ALL HARDWARE SEEMS TO BE IN PLACE AND PATIENT DID NOT HAVE OCCURRENCES OF FAINTING, BLOOD IN STOOL OR ABDOMINAL PAIN. THE PATIENT CONTINUES TO TAKE MEDICATION FOR BACK DISCOMFORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PASS LP	PEDICLE SCREW	MNI	MEDICREA INTERNATIONAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR		Hospitalization