FDA Adverse Event Injury Summary report: N

TI MIRS LOCKING CAP

MDR report key: 2873752 · Received December 14, 2012

Report

Report Number: 8030965-2012-01576
Event Type: Injury
Date Received: December 14, 2012
Report Date: November 15, 2012
Manufacturer: SYNTHES GMBH
Product Code: NKB
PMA / PMN Number: K113044
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Additional Manufacturer Narrative · 1

DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATIONS. THE REVIEW OF THE RAW-MATERIAL TEST CERTIFICATE AND THE MANUFACTURING DOCUMENTS HAD SHOWN NO DEVIATIONS TO MATERIAL ANALYSIS, STRENGTH, STRUCTURAL STABILITY AND MANUFACTURING. THE VALUES CORRESPOND TO THE AO/ASIF SPECIFICATIONS AND TO THE INTERNATIONAL NORMS. THE IMPLANT HAS SEVERAL TRACKS OF INSTRUMENTS AND CONTACT WITH OTHER OBJECTS. THE MEASUREMENTS OF THE IMPLANTS SHOW THAT THERE ARE NO DEVIATIONS TO OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED A PATIENT WAS TREATED WITH A MIRS CONSTRUCT ON (B)(6) 2011. POST-OPERATIVELY X-RAYS TAKEN SHOW THE LOCKING CAP WAS LOOSE. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 AND THE LOCKING CAP WAS REMOVED AND REPLACED WITH A NEW ONE. THIS REPORT IS #1 OF 3 FOR THE SAME EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TI MIRS LOCKING CAP	TI MIRS LOCKING CAP	NKB	SYNTHES GMBH		7752289

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention	SCREW, ROD