CD HORIZON® SPINAL SYSTEM
Report
- Report Number
- 1030489-2013-03112
- Event Type
- Malfunction
- Date Received
- July 25, 2013
- Date of Event
- July 18, 2013
- Report Date
- July 25, 2014
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- NKB
- PMA / PMN Number
- K052187
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: IMPLANT DATE: (B)(6) 2013; PT DEMOGRAPHICS: MALE, (B)(6), DOB (B)(6) 1990, WEIGHT (B)(6).I T WAS REPORTED THAT THE PROCEDURE WAS A KYPHOSIS CORRECTION. WHEN LOCKING THE COBALT CHROME ROD DOWN INTO THE REDUCTION SCREWS WITH REDUCTION SET SCREWS, THE ROD WOULD CONTINUE TO SLIP. SURGEONS CONFIRMED THAT THE ROD WAS FULLY SEATED, AND EVEN WHEN BREAKING THE SET SCREW OFF AND CHECKING WITH A T27 DRIVER IF THEY COULD BE FURTHER TIGHTENED, THE ROD WOULD STILL SLIP. THIS OCCURRED ON ALL 8 REDUCTION SCREWS. THE SURGEONS RESORTED TO BREAKING OFF THE TABS OF THE REDUCTION SCREWS AND SEATING THE ROD WITH THE BEALE ROD REDUCER AND THEN USING 8 X STANDARD LEGACY 5.5 BREAKOFF SET SCREWS ((B)(4)), WHICH SOLVED THE ISSUE. SURGEONS ARE CONCERNED THAT THE GRIP OF THE REDUCTION SET SCREWS WERE FAULTY HENCE WHY THEY WERE NOT HOLDING CORRECTION IN THE SPINE. THEY WERE ALSO CONCERNED THAT THE NIPPLE ON THE SET SCREWS WERE NOT FLATTENED OUT AS THEY SHOULD BE WHEN EXPLANTING THEM. UPDATED REF FROM REP ON (B)(6) 2013: THIS IS A SECOND REPORTED EVENT DUE COMPLICATIONS ARISING FROM THE ORIGINAL REPORT DONE IN (B)(6) 2013. THE REFERENCE NUMBER FOR THE ORIGINAL REPORT IS (B)(4), WITH {NAME} REFERENCE NUMBER (B)(4). THE REDUCTION SET SCREWS AT THE BOTTOM OF THE CONSTRUCT (AT LEVEL L2) HAVE ALLOWED THE ROD TO SLIP OUT OF THE TULIP HEAD OF THE SCREW. THE SURGEON IS NOW MONITORING THE PATIENT AS TO WHETHER FURTHER SURGICAL INTERVENTION IS REQUIRED. THE QUESTION HAS BEEN RAISED THAT IS THERE A WEAKNESS IN THE REDUCTION SCREWS AND SET SCREWS? OVERALL, THE SURGEON IS NOT HAPPY WITH THE RESULT AND WOULD LIKE A PROMPT RESPONSE. PARTS RECEIVED: 10 - SET SCREW (B)(4), LEGACY 5.5 RED PLUG TI (B)(4) 20 - SET SCREW (B)(4), LEGACY 5.5 RED PLUG TI (B)(4) 30 - SET SCREW (B)(4), LEGACY 5.5 RED PLUG TI (B)(4) 40 - SET SCREW (B)(4), LEGACY 5.5 RED PLUG TI (B)(4) 50 - SET SCREW (B)(4), LEGACY 5.5 RED PLUG TI (B)(4) 70 - SET SCREW (B)(4), LEGACY 5.5 RED PLUG TI (B)(4) 90 - BONE SCREW (B)(4) L5.5 RED MAS 6.5X50 100 - BONE SCREW (B)(4) L5.5 RED MAS 6.5X50 110 - BONE SCREW (B)(4) L5.5 RED MAS 6.5X50 120 - BONE SCREW (B)(4) L5.5 RED MAS 6.5X50 130 - BONE SCREW (B)(4) L5.5 RED MAS 7.5X50 140 - BONE SCREW (B)(4) L5.5 RED MAS 7.5X50 150 - BONE SCREW (B)(4) L5.5 RED MAS 6.5X45 160 - BONE SCREW (B)(4) L5.5 RED MAS 6.5X45 PLI10: SET SCREW LOCATIONS WITHIN CONSTRUCT UNKNOWN. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY, AS WELL AS ROD INTERFACE WITNESS MARKS ON SET SCREW FACE ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN BENCH COMPARISON SAMPLES. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN REDUCTION MAS AT FINAL TIGHTENING. PLI20: SET SCREW LOCATIONS WITHIN CONSTRUCT UNKNOWN. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY, AS WELL AS ROD INTERFACE WITNESS MARKS ON SET SCREW FACE ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN BENCH COMPARISON SAMPLES. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN FAS AT FINAL TIGHTENING. PLI30: SET SCREW LOCATIONS WITHIN CONSTRUCT UNKNOWN. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY, AS WELL AS ROD INTERFACE WITNESS MARKS ON SET SCREW FACE ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN BENCH COMPARISON SAMPLES. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN FAS AT FINAL TIGHTENING. PLI40: SET SCREW LOCATIONS WITHIN CONSTRUCT UNKNOWN. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY, AS WELL AS ROD INTERFACE WITNESS MARKS ON SET SCREW FACE ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN BENCH COMPARISON SAMPLES. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN FAS AT FINAL TIGHTENING. PLI50: SET SCREW LOCATIONS WITHIN CONSTRUCT UNKNOWN. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY, AS WELL AS ROD INTERFACE WITNESS MARKS ON SET SCREW FACE ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN BENCH COMPARISON SAMPLES. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN FAS AT FINAL TIGHTENING. PLI70: SET SCREW LOCATIONS WITHIN CONSTRUCT UNKNOWN. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY, AS WELL AS ROD INTERFACE WITNESS MARKS ON SET SCREW FACE ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN BENCH COMPARISON SAMPLES. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN FAS AT FINAL TIGHTENING. PLI'S 80, 170, 180, 200, 210: NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. NO CORRECTIVE ACTION IS POSSIBLE BASED ON THE CURRENT DATA. WE WILL CONTINUE TO MONITOR FOR TRENDS AS MORE DEFINITIVE DATA IS COLLECTED. PLI'S 90, 100, 110, 120, 130, 140, 150, <(>&<)> 160: ONLY THE TOP PORTION OF THE REDUCTION MAS HEADS HAVE BEEN RETURNED FOR ANALYSIS. NO APPARENT DAMAGE TO THREADS. NO ADDITIONAL INFORMATION CAN BE DETERMINED FROM RETURNED IMPLANTS. DEVICES RETURNED UNSUITABLE FOR PRODUCT EVALUATION. A REVIEW OF ALL DOCUMENTS INCLUDED IN THE DHR FOR LOTS 0219953W, 0227640W, 0220838W, AND 0224833W DID NOT IDENTIFY ANY APPLICABLE NO N-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE. A QUERY OF THE ENTIRE COMPLAINT HISTORY OF THESE PARTS WERE CONDUCTED ON (B)(4) 2013, RANGING FROM (B)(4) 2011 TO (B)(4) 2013, WHICH DID NOT CONTRIBUTE ANY ADDITIONAL INFORMATION TO THIS INVESTIGATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME - THIS INVESTIGATION IS CONSIDERED CLOSED. CRITERIA NOT MET FOR ESCALATION: NOT A NON-CONFORMANCE (MANUFACTURING, LABELING, STERILITY, STORAGE CONDITIONS, SHELF LIFE), AND NOT SEVERITY 4 OR 5 IN PD051 ((B)(4)), DESIGN RISK ANALYSIS WORK INSTRUCTION. PRODUCT ANALYSIS #(B)(4): SET SCREW LOCATIONS WITHIN CONSTRUCT UNKNOWN. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY, AS WELL AS ROD INTERFACE WITNESS MARKS ON SET SCREW FACE ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN BENCH COMPARISON SAMPLES. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN REDUCTION MAS AT FINAL TIGHTENING. (B)(6).
ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT SET SCREW LOCATIONS WITHIN CONSTRUCT UNKNOWN. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY, AS WELL AS ROD INTERFACE WITNESS MARKS ON SET SCREW FACE ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN BENCH COMPARISON SAMPLES. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN FAS AT FINAL TIGHTENING.
(B)(6). (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.
THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF RADIOGRAPHIC IMAGES SHOW A COMPLEX SCOLIOSIS SURGERY PERFORMED WITH CONSTRUCT FROM T1 TO L2. INITIAL FILMS SHOW GOOD POSITION OF ALL ELEMENTS WITH THE EXCEPTION OF THE RODS BEING SOMEWHAT SHORT CAUDALLY. SUBSEQUENT FILMS SHOW PULL OUT OF THE ROD FROM THE L2 SCREWS BILATERALLY. INITIAL CONSTRUCT SUGGESTED PROFOUND COMPRESSION ACROSS L1/2 THAT COULD HAVE CONTRIBUTED TO THE ROD/SCREW STRESSES. SOME OF THE ROD ALSO CONSISTS OF THE SMALL HEX ROTATION FITTING, WHICH COULD HAVE BEEN PART OF THE SCREW/ROD INTERFACE, FURTHER WEAKENING THE PURCHASE.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IMPLANT DATE: (B)(6) 2013; PT DEMOGRAPHICS: MALE, (B)(6), DOB (B)(6) 1990, WEIGHT (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS A KYPHOSIS CORRECTION. WHEN LOCKING THE COBALT CHROME ROD DOWN INTO THE REDUCTION SCREWS WITH REDUCTION SET SCREWS, THE ROD WOULD CONTINUE TO SLIP. SURGEONS CONFIRMED THAT THE ROD WAS FULLY SEATED, AND EVEN WHEN BREAKING THE SET SCREW OFF AND CHECKING WITH A T27 DRIVER IF THEY COULD BE FURTHER TIGHTENED, THE ROD WOULD STILL SLIP. THIS OCCURRED ON ALL 8 REDUCTION SCREWS. THE SURGEONS RESORTED TO BREAKING OFF THE TABS OF THE REDUCTION SCREWS AND SEATING THE ROD WITH THE BEALE ROD REDUCER AND THEN USING 8 X STANDARD LEGACY 5.5 BREAKOFF SET SCREWS ((B)(4)), WHICH SOLVED THE ISSUE. SURGEONS ARE CONCERNED THAT THE GRIP OF THE REDUCTION SET SCREWS WERE FAULTY HENCE WHY THEY WERE NOT HOLDING CORRECTION IN THE SPINE. THEY WERE ALSO CONCERNED THAT THE NIPPLE ON THE SET SCREWS WERE NOT FLATTENED OUT AS THEY SHOULD BE WHEN EXPLANTING THEM. UPDATED REF FROM REP ON (B)(6) 2013: THIS IS A SECOND REPORTED EVENT DUE COMPLICATIONS ARISING FROM THE ORIGINAL REPORT DONE IN (B)(6) 2013. THE REFERENCE NUMBER FOR THE ORIGINAL REPORT IS (B)(4), WITH {NAME} REFERENCE NUMBER (B)(4). THE REDUCTION SET SCREWS AT THE BOTTOM OF THE CONSTRUCT (AT LEVEL L2) HAVE ALLOWED THE ROD TO SLIP OUT OF THE TULIP HEAD OF THE SCREW. THE SURGEON IS NOW MONITORING THE PATIENT AS TO WHETHER FURTHER SURGICAL INTERVENTION IS REQUIRED. THE QUESTION HAS BEEN RAISED THAT IS THERE A WEAKNESS IN THE REDUCTION SCREWS AND SET SCREWS? OVERALL, THE SURGEON IS NOT HAPPY WITH THE RESULT AND WOULD LIKE A PROMPT RESPONSE.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE FOR KYPHOSIS CORRECTION. DURING THE PROCEDURE, "WHEN LOCKING THE ROD DOWN INTO THE REDUCTION SCREWS WITH SETSCREWS, THE ROD SLIPPED. SURGEON CONFIRMED THAT THE ROD WAS FULLY SEATED AND EVEN WHEN BREAKING THE SET SCREW OFF AND CHECKING WITH A T27DRIVER IF THEY COULD BE FURTHER TIGHTENED, THE ROD WOULD STILL SLIP. THE SURGEON RESORTED TO BREAKING OFF THE TABS OF THE REDUCTION SCREWS AND SEATING THE ROD WITH THE ROD REDUCER AND THEN USED STANDARD BREAKOFF SETSCREWS WHICH SOLVED THE ISSUE." PROCEDURE WAS ABLE TO BE COMPLETED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349029 | CD HORIZON® SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | WARSAW ORTHOPEDICS | 0219953W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00023 YR | Required Intervention |