UNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW
Received Jun 7, 2018 · Event occurred May 6, 2018
Report 3006460162-2018-00034 · MDR key 7579255
Device
Generic name
Unknown Pedicle Screw
Manufacturer
Orthopediatrics, IncModel number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- No Apparent Adverse Event
- Adverse Event Without Identified Device or Use Problem
- No Apparent Adverse Event
Patient
12 YR
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL DEVICES: ITEM: 00-1003-4001, RESPONSE LARGE SET SCREW, LOT: UNKNOWN, QUANTITY: 19. ITEM: 00-1003-6001, RESPONSE 5.5 MM ROD, 500 MM, LOT: UNKNOWN, QUANTITY: 2. ITEM: 00-1300-2630, RESPONSE 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0 MM X 30 MM, LOT: UNKNOWN, QUANTITY: 9. ITEM: 00-1300-2635, RESPONSE 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0 MM X 35 MM, LOT: UNKNOWN, QUANTITY: 3. ITEM: 00-1300-2740, RESPONSE 5.5/6.0 POLYAXIAL PEDICLE SCREW 7.0 MM X 40 MM, LOT: UNKNOWN. ITEM: 00-1300-3041, RESPONSE ADJUSTABLE CROSS CONNECTOR SMALL, LOT: UNKNOWN. ITEM: 00-1300-5034, RESPONSE 5.5/6.0 FIXED CROSS CONNECTOR, 34 MM, LOT: UNKNOWN. ITEM: 00-1300-3735, RESPONSE 5.5/6.0 POLYAXIAL REDUCTION PEDICLE SCREW 7, LOT: UNKNOWN, QUANTITY: 2. ITEM: 00-1300-3860, RESPONSE 5.5/6.0 POLYAXIAL REDUCTION PEDICLE SCREW 8, LOT: UNKNOWN. ITEM: 00-1300-3870, RESPONSE 5.5/6.0 POLYAXIAL REDUCTION PEDICLE SCREW 8, LOT: UNKNOWN. ITEM: 01-1300-3000, 1.25 MM ROUNDED GUIDE WIRE 100 MM LENGTH, LOT: UNKNOWN, QUANTITY: 2. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF THE RESPONSE SPINE SYSTEM, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION. A PEDICLE SCREW DIRECTLY BELOW AN OPEN WOUND WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTIONS TO INITIAL REPORT BASED ON INITIAL REPORTING OF THE EVENT. SURGEON REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE BUT WAS A RESULT OF THE PATIENT CONDITION. H6 - DEVICE CODE: 2993. METHOD CODES: 4114-4111. RESULT CODES: 213. CONCLUSION CODES: 50.