MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 8.0X50; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723850
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 that patient returned for revision of spine instrumentation due to left side s1 pedicle screw disengaging from rod.If other, describe.L3-s1 posterior fusion with alif l5s1 and lateral cage l3-4.Did the patient experience a post-op device malfunction? yes.If yes, please describe.Left side s1 pedicle screw disengaging from rod.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? no.Did the patient require revision surgery or hardware removal? yes.Was device explanted? true.Did patient require revision surgery? true.If yes, date of revision surgery.On (b)(6) 2019.Patient status/ outcome / consequences: unknown.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? unknown.Is the patient part of a clinical study? unknown.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).Udi: ((b)(4).Visual examination of the returned screw features signs of use such as impacted bone tissue, surface markings.However, the screw featured no signs of loosening.Although, x-ray image of the device was provided, it cannot be confirmed that the screw was loose.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 poly screw loosening postoperatively cannot be determined from the sample and information provided.A potential root cause cannot be determined since the report of the screw 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: 5.5 EXP VERSE FEN SCR 8.0X50
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8459713
• Report Number: 1526439-2019-51491
• Device Sequence Number: 2818790
• Product Code: PML
• UDI-Device Identifier: 10705034402758
• UDI-Public: (01)10705034402758
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 199723850
• Device Catalogue Number: 199723850
• Device Lot Number: 168866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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