3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM
Report
- Report Number
- 8030965-2018-50949
- Event Type
- Injury
- Date Received
- February 8, 2018
- Report Date
- January 16, 2018
- Manufacturer
- SYNTHES PRODUKTIONS GMBH
- Product Code
- NKG
- UDI-DI
- 07611819327900
- PMA / PMN Number
- K142838
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. UPDATED CONCOMITANT DEVICES. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART NO.: 04.614.022S; LOT NO.: L394074; MANUFACTURING LOCATION: SELZACH; SUPPLIER: (B)(4); RELEASE TO WAREHOUSE DATE: 28.APR.2017; EXPIRY DATE: 01.APR.2027. NO NONCONFORMANCES (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 04.614.022 / H298425 WAS MANUFACTURED IN US, ELMIRA. UPDATE 10-APR-2018 - BRANDYWINE DHR REVIEW: PART NO: 04.614.022; LOT NO: H298425; MANUFACTURING SITE: BRANDYWINE; SUPPLIER DHR REIVEW: N/A; RELEASE TO WAREHOUSE DATE: 14-FEB-2017; NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: THE FOLLOWING INVESTIGATION FLOW WAS PERFORMED: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) REVEALED THAT THE COMPLAINT DEVICE WAS RECEIVED IN ASSEMBLED CONDITION. MINOR WEAR CONSISTANT WITH IMPLANTATION AND SUBSEQUENT EXPLANTATION EXIST. HOWEVER, NO DAMAGE THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WAS OBSERVED. NO X-RAYS SHOWING THE REPORTED LOOSENING CONDITION WERE PROVIDED. THEREFORE THE REPORTED COMPLAINT CONDITION WAS NOT ABLE TO BE CONFIRMED. REPLICATION OF THIS REPORTED POSTOPERATIVE EVENT COULD NOT BE ACHIEVED AT CQ. THE RETURNED IMPLANT WAS MAUFACTURED IN APRIL 2017. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. TABULATED PRODUCT DRAWING FOR THE FAMILY OF 3.5MM TITANIUM TOP LOADING CANCELLOUS SCREW ASSEMBLIES WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. A RELEVANT DIMENSIONAL INSPECTION WAS NOT ABLE TO BE PERFORMED AT CQ DUE TO THE ASSEMBLED CONDITION OF THE DEVICE. THIS COMPLAINT WAS NOT ABLE TO BE CONFIRMED AND NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL DEVICE PRODUCT CODES: KWP, MNH, MNI. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.614.022S, LOT# L394074. MANUFACTURING LOCATION: SELZACH, RELEASE TO WAREHOUSE DATE: APR 28, 2017, EXPIRY DATE: APR 01, 20127. NON-STERILE PART# 04.614.022, LOT# H298425< MANUFACTURING LOCATION: BRANDYWINE, RELEASE TO WAREHOUSE DATE: FEB 14, 2017. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
CONCOMITANT DEVICES REPORTED: CANCELLOUSSCR SYNAPSE Ø3.5 L22 TAN (PART# 04.614.022S, LOT# L394074, QUANTITY 1). LOCKSCR SYNAPSE TAN (PART# 04.614.508S, LOT# L495154, QUANTITY 1). LOCKSCR SYNAPSE TAN (PART# 04.614.508S, LOT# L524538, QUANTITY 1). ROD Ø3.5 L240 TI GOLD (PART# 498.957S, LOT# L221311, QUANTITY 1). OCCIPITAL-PLATE (PART# 04.161.011 , LOT# 8813705, QUANTITY 1). OCCIPIT-SCREW (PART# 04.601.108, LOT# 9196111, QUANTITY 1). OCCIPIT-SCREW (PART# 04.601.108, LOT# 9947302, QUANTITY 1). OCCIPIT-SCREW (PART# 04.601.108, LOT# 9668741, QUANTITY 1). OCCIPIT-SCREW (PART# 04.601.110, LOT# L272438, QUANTITY 1). ROD (PART# 498.957, LOT# L163874, QUANTITY 1). LOCKING SCREW (PART# 406.104, LOT# H274186 , QUANTITY 2).
IT WAS FURTHER REPORTED THAT AFTER A MEDICAL FOLLOW-UP, THE SCHEDULED RE-OPERATION WAS PERFORMED ON (B)(6) 2018. DURING THE SURGERY, TWO SCREWS WERE REMOVED AND PATIENT WAS IMPLANTED WITH NON-SYNTHES IMPLANTS. CONCOMITANT DEVICES REPORTED: CANCELLOUSSCR SYNAPSE Ø3.5 L22 TAN (PART# 04.614.022S, LOT# L394074, QUANTITY 1). LOCKSCR SYNAPSE TAN (PART# 04.614.508S, LOT# L495154, QUANTITY 1). LOCKSCR SYNAPSE TAN (PART# 04.614.508S, LOT# L524538, QUANTITY 1). ROD Ø3.5 L240 TI GOLD (PART# 498.957S, LOT# L221311, QUANTITY 1).
CONCOMITANT MEDICAL PRODUCTS: 3.5MM CANCELLOUS POLYAXIAL SCREW 22MM (04.614.022S, LOT L394074, QUANTITY 1), TITANIUM LOCKING SCREW (04.614.508S, LOT L495154, QUANTITY 1), TITANIUM LOCKING SCREW (04.614.508S, LOT L524538, QUANTITY 1), 3.5MM TITANIUM ROD 240MM (498.957S LOT L221311, QUANTITY 1), TITANIUM OCCIPITAL PLATE LATERAL WEDGE 50MM WIDTH (04.161.011 LOT 8813705, QUANTITY 1), 4.5MM TITANIUM OCCIPITAL SCREW 8MM (04.601.108 LOT 9196111, QUANTITY 1), 4.5MM TITANIUM OCCIPITAL SCREW 8MM (04.601.108 LOT 9947302, QUANTITY 1), 4.5MM TITANIUM OCCIPITAL SCREW 8MM (04.601.108 LOT 9668741, QUANTITY 1), 4.5MM TITANIUM OCCIPITAL SCREW 10MM (04.601.110 LOT L272438, QUANTITY 1), 3.5MM TITANIUM ROD 240MM (498.957 LOT L163874, QUANTITY 1), TITANIUM AXON LOCKING SCREW STARDRIVE (406.104 LOT H274186, QUANTITY 2)
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT, DOB & WEIGHT NOT PROVIDED FOR REPORTING. DATE OF EVENT: UNKNOWN. DEVICE NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. ADDITIONAL 510K'S K090549/K070573. (B)(4): IT WAS REPORTED THAT SCREW HEAD WAS FOUND TO HAVE MOVED POSTOPERATIVELY. THERE WAS A CORRECTION LOSS ON THE IMAGING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PART NOT BEING RETURNED PER REPORTER. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE SPINE SURGERY WAS PERFORMED BY USING THE SYNAPSE SYSTEM. THE FIXED AREA WAS O¿C2. ON (B)(6) 2018, THERE WAS A CORRECTION LOSS FOUND ON THE POST-OPERATIVE IMAGES. WHEN CHECKED, IT WAS FOUND THAT THE HEAD OF THE COMPLAINT DEVICE HAD BEEN MOVED. THERE WAS NO PROBLEM WITH A DEVICE HANDLING TECHNIQUE DURING THE SURGERY. A FURTHER MEDICAL FOLLOW-UP WAS PLANNED. THE SURGERY WAS COMPLETED WITH NO DELAY. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97940 | 3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM | ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION | NKG | SYNTHES PRODUKTIONS GMBH | L394074 | 07611819327900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |