MAUDE Adverse Event Report: DEPUY SPINE INC SFX,5.5,TI, MED, SIZE A5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	189401405
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4), unknown.The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported on (b)(6) 2019, after a revision surgery last (b)(6) 2019, the surgeon recognized that the both set screw and rod were came off dissociated under x-ray.Surgeon suspected that the damage of the screw thread was because the surgeon did not tighten the set screw forcibly.The revision surgery performed on (b)(6) 2019.Procedure was successfully completed, and the patient¿s condition is now stable and under monitoring.Concomitant device reported: unknown rods (part # unknown, lot # unknown, quantity unknown).This complaint involves four (4) devices.
Additional Manufacturer Narrative
Product complaint (b)(4).Udi (b)(4).The connector features signs of use such as surface markings.However, the connector featured no signs of loosening.No postoperative x-rays were provided to confirm the medial connector loosening.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The root cause of the medial connector loosening postoperatively cannot be determined from the sample and information provided.A potential root cause cannot be determined since the report of the connector loosening could not be confirmed or replicated.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SFX,5.5,TI, MED, SIZE A5
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8732293
• Report Number: 1526439-2019-51800
• Device Sequence Number: 13965353
• Product Code: NKB
• UDI-Device Identifier: 10705034168128
• UDI-Public: (01)10705034168128
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 189401405
• Device Catalogue Number: 189401405
• Device Lot Number: OM10031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR